Federal regulatory agency
Appears in 152 stories
Will review the avexitide New Drug Application
Post-bariatric hypoglycemia has no FDA-approved treatment. In August, Amylyx Pharmaceuticals reported that its Phase III LUCIDITY trial showed avexitide cut dangerous hypoglycemic events by 55% versus placebo (p=0.000003).
Updated 5 hours ago
Cleared MT027 for two Phase 2 programs; granted Orphan Drug and Fast Track designations
The FDA cleared T-MAXIMUM's off-the-shelf CAR-T, MT027, for a Phase 2 trial in brain metastases from lung and breast cancer. It's the second Phase 2 clearance for the therapy, which targets the tumor protein B7-H3 and is delivered directly into the brain.
Updated 9 hours ago
Approves drugs and publishes the Orange Book patent list the study analyzed
The average FDA-approved drug now carries more than three times as many patents as it did in 1990. A JAMA study of 1,981 small-molecule drugs found the mean patent count per drug rose from 2.1 to 6.9 between 1990 and 2019.
Updated Yesterday
Regulator that granted the 510(k) clearance
RingConn, the Chinese smart ring maker owned by Shenzhen Ninenovo Technology Limited, won 510(k) clearance from the U.S. Food and Drug Administration (FDA) for non-invasive blood oxygen (SpO2) measurement. The FDA issued its decision Oct. 2 under clearance No. K260490, and RingConn announced it Oct. 10, calling it a first for a Chinese smart ring company.
Updated 2 days ago
Conducted testing and issued recall notice
The Utah Department of Agriculture and Food issued a recall for one-pound bags of Gardeners Basics Waltham 29 Broccoli Sprouting Seeds after the FDA found salmonella in a bulk seed lot. The seeds were sold online nationwide through Amazon, TikTok Shop, Walmart, eBay, Etsy and the company's website.
Approved WELTRUZA on October 9, 2026
Teva's WELTRUZA is the first once-monthly subcutaneous injection of olanzapine for schizophrenia. Patients skip the loading doses, oral supplementation, and post-injection observation that shaped use of the prior injectable form.
Actively phasing out animal testing requirements in favor of organoid and AI-based methods
Johns Hopkins engineers grew miniature brains from patients' skin cells and found each psychiatric disorder has its own electrical fingerprint. Using machine learning, the organoids identified schizophrenia and bipolar disorder with 83% accuracy from firing patterns alone, rising to 92% after subtle electric stimulation.
Approved the CardioMEMS patient-facing app update
Heart failure patients with Abbott's implanted sensor can now see their own pulmonary artery pressure readings on their smartphones. The FDA approved the update on October 5, 2026, along with a feature that lets clinicians send medication adjustment instructions directly to patients.
Updated 3 days ago
Granted 510(k) clearance for K261612
A five-minute MRI scan can now break down a patient's muscle, fat, and liver fat into measured numbers. The FDA cleared AIRS Medical's SwiftSight Body Composition on October 1, and SimonMed Imaging will run it inside SimonMed Longevity, its self-pay whole-body MRI service.
Updated 4 days ago
Cleared HCB303 IND on October 5, 2026
The U.S. Food and Drug Administration cleared HanchorBio's investigational new drug application for HCB303 on October 5, and three days later the company filed the same drug with Taiwan's TFDA. HCB303 is a single fusion protein that blocks three immune pathways: TIGIT, PD-L1, and CD47.
Reviewing both drugs
GSK closed its $10.6 billion purchase of Nuvalent in September, netting out to about $9.4 billion in cash. Both lung cancer drugs central to the deal were still under FDA review at closing; a ruling on neladalkib is due November 27.
Granted breakthrough therapy designations
The FDA granted AbbVie's experimental cancer drug Temab-A two breakthrough therapy designations on October 7. One covers colorectal cancer, the other non-small cell lung cancer. The designations speed up development and review for drugs that show early evidence of substantial improvement over existing therapies.
Updated 5 days ago
Granted 510(k) clearance to Bayesian's sepsis flagging device in April 2026
Since October 1, 2026, hospitals using Bayesian Health's continuous AI sepsis monitor can bill Medicare for an extra payment of up to $61.84 per eligible discharge. The Centers for Medicare and Medicaid Services (CMS) approved the add-on payment in its FY 2027 Inpatient Prospective Payment System Final Rule.
Updated 6 days ago
Cleared Cala kIQ Plus via 510(k) pathway
Cala Health began selling its kIQ Plus tremor therapy wearable nationwide on October 6. The wrist-worn device, cleared by the FDA in March, is the first tremor stimulator with multiple therapy modes and adaptive calibration, the company says.
Granted RAG-18 Orphan Drug and Rare Pediatric Disease designations
Three boys with Duchenne muscular dystrophy received monthly infusions of an experimental drug. Four months later, muscle biopsies showed 3.5- to 5.3-fold increases in utrophin, a protein that can substitute for the missing dystrophin.
Updated 7 days ago
Approved Jaypirca's first-line CLL/SLL indication on October 2, 2026
The FDA on October 2 approved Eli Lilly's Jaypirca for newly diagnosed chronic lymphocytic leukemia, making it the first non-covalent BTK inhibitor available as initial therapy. The approval covers adults with previously untreated CLL or small lymphocytic lymphoma who lack a 17p deletion, a subgroup that makes up roughly 92% to 95% of new cases.
Launched the Expedited IND Pilot on September 15, 2026
A first-in-human drug trial can take up to two years to complete in the United States. The FDA's pilot, part of Operation TrialBlazer, tests a faster path to starting such trials by having sponsors partner with research institutions while the agency reviews application pieces as they are finished.
Updated Oct 4
Regulator that approved and expanded PearlMatrix indications
Hospitals that use PearlMatrix, a peptide-enhanced bone graft proven to speed lumbar fusion, can now claim up to 65% of its added cost back from Medicare. The Centers for Medicare & Medicaid Services (CMS) granted the graft New Technology Add-on Payment (NTAP) status, effective October 1, 2026.
Updated Oct 2
Reviewing two giredestrant applications under priority review
Patients with estrogen receptor (ER)-positive advanced breast cancer who progress on a CDK4/6 inhibitor have few options left. The Phase III evERA trial found that giredestrant, a pill that degrades the estrogen receptor, plus everolimus cut the risk of progression or death by 44% overall and 62% in ESR1-mutated tumors.
Reviewing the AMT-130 Biologics License Application
uniQure reported four-year data from its Huntington's gene therapy trial on September 29. The results were mixed: the main composite measure showed 44% slower decline, short of statistical significance, while a functional-capacity measure showed 61% slower decline.
Updated Oct 1
Approved VYEPTI for migraine prevention in February 2020
Migraine patients who try one CGRP-blocking drug and don't get relief now have evidence that switching to a different one can work. Lundbeck's Phase IV THRIVE trial found that after 24 weeks on VYEPTI (eptinezumab), 60% of participants reported being 'much improved' or 'very much improved.'
Classified both recalls as Class II
An Indian drugmaker has recalled a common blood pressure medicine twice since June. Inventia Healthcare pulled more than 25,000 bottles of its 25 mg chlorthalidone tablets after lab tests showed the pills dissolve too slowly for proper absorption.
Approved orforglipron (Foundayo) for obesity in April 2026; reviewing the type 2 diabetes application
Millions with type 2 diabetes manage blood sugar with daily injections. Lilly's Foundayo is a pill that could replace them, and in its largest trial it matched insulin on heart safety while cutting weight and blood sugar more.
Granted premarket approval for SimpleScreen CRC on July 24, 2026
Abbott began selling SimpleScreen CRC on September 30, giving average-risk Americans 45 and older a second FDA-approved blood test for colorectal cancer screening. The test reads cell-free DNA from a simple blood draw for signals associated with cancer. Abbott is betting it reaches people who never complete a colonoscopy or stool test.
Updated Sep 30
Will review Vanda's DSWPD application
Vanda Pharmaceuticals said a late-stage trial of HETLIOZ (tasimelteon) shifted the timing of sleep onset 37.1 minutes earlier than placebo in adults with delayed sleep-wake phase disorder (DSWPD). The result was statistically significant (p=0.022), and 60% of treated patients advanced their sleep by at least 30 minutes, versus 15% on placebo.
Granted Premarket Approval for RefluxStop
The Food and Drug Administration approved Implantica's RefluxStop device on August 20, clearing the way for the first new anti-reflux implant to enter the U.S. market since Johnson & Johnson's Linx. On September 29, the company kicked off its commercial launch at the American Foregut Society's annual meeting in Washington, drawing an over-capacity crowd of more than 120 surgeons and gastroenterologists. The launch venue was chosen to put the device in front of the specialists who decide which reflux patients get surgery.
Updated Sep 29
Cleared NouvSight001 for a Phase I/II trial and granted a special exemption
About 1.5 million people worldwide have retinitis pigmentosa, an inherited disease that destroys the retina's light-sensing cells and can end in blindness. The only approved treatment covers patients with a specific RPE65 gene mutation — a small fraction of the affected population.
Found the Phase 2 data insufficient for accelerated approval
Merck and Daiichi Sankyo withdrew their US application for ifinatamab deruxtecan, an experimental antibody-drug conjugate for extensive-stage small cell lung cancer, an aggressive disease that has resisted most new treatments. The FDA had told the companies their Phase 2 data were not enough to support accelerated approval, and the bid was pulled on September 25.
Reviewing Kyverna's rolling application; agreed on KYSA-8 primary endpoint
Novartis paused its autoimmune CAR-T trials this month after three patients died from a severe immune reaction, and Bristol Myers paused its own over similar inflammatory events. The same week, Kyverna Therapeutics released 12 months of follow-up data on miv-cel, its rival therapy, reporting sustained improvement in stiff person syndrome patients with no high-grade immune toxicity.
Updated Sep 24
Approved SELUTION SLR for coronary in-stent restenosis; designated it a Breakthrough Device
On September 21, the FDA approved the first sirolimus drug-eluting balloon for coronary use in the US. Cordis' SELUTION SLR expands inside a narrowed artery, releases sirolimus for up to 90 days, then is removed. No permanent implant stays behind.
Updated Sep 23
Will review barzolvolimab BLA; possible advisory committee
Celldex's experimental antibody barzolvolimab beat placebo in two Phase 3 trials for chronic spontaneous urticaria, the condition behind recurring hives and severe itching. Roughly 42% to 46% of treated patients were completely symptom-free at 12 weeks, versus about 10% on placebo. The drug works by depleting the mast cells that drive the disease—a mechanism no approved CSU therapy uses.
Updated Sep 22
Will review ulefnersen for a potential expedited approval
FUS-ALS patients have no approved drug targeting the cause of their disease. On September 22, an experimental therapy cleared a key hurdle: a Phase 3 trial showed ulefnersen, an RNA-targeted drug, improved function and survival versus placebo.
Admissibility authority for prescription drugs entering the US
Starting October 22, prescription drugs mailed into the United States will require formal customs entry instead of the $800-or-less de minimis path. Customs and Border Protection made that suspension indefinite for postal arrivals in a June 24 rule.
Approved AQNEURSA for ataxia in A-T patients
About 1 in 40,000 people are born with ataxia-telangiectasia, a genetic disease that destroys the cerebellum and progressively strips muscle control, typically starting in early childhood. Until this week, no drug was approved for it anywhere in the world. IntraBio's AQNEURSA (levacetylleucine) just became the first.
Updated Sep 21
Approved Fayuvi with orphan drug, fast track, and breakthrough therapy designations
Children with Sanfilippo syndrome type A lose the ability to walk, talk, and eventually swallow, typically dying in their mid-teens. On September 17, the FDA approved Fayuvi, a one-time intravenous gene therapy that delivers a working copy of the SGSH gene — the first treatment that changes the disease course rather than managing symptoms.
Updated Sep 19
Clearing authority for medical devices sold in the US
The Food and Drug Administration cleared Medtronic's LigaSure vessel-sealing jaw for use on its Hugo surgical robot on September 16. LigaSure has sealed vessels in 45 million procedures over two decades; this is its first robotic version, cutting and closing vessels up to 7 millimeters in about two seconds each.
Updated Sep 18
Granted 510(k) clearance to Aptitude's next-gen Metrix COVID test
The FDA granted Aptitude Medical Systems its first 510(k) clearance for the next-generation Metrix COVID test, a handheld molecular diagnostic for at-home and clinic use. The test delivers roughly three times the analytical sensitivity of the original emergency-authorized version and returns results 30% faster.
Reviewing azetukalner New Drug Application for focal seizures
Xenon Pharmaceuticals stopped enrolling new patients in its Phase 3 depression and bipolar disorder trials on September 17 after participants reported neuropsychiatric side effects, including a small number of psychosis cases. The company's stock fell more than 25% the next day.
Regulator; previously said RVEF alone insufficient for HLHS approval; willing to meet post-trial
Longeveron's stem cell therapy for a rare pediatric heart disease missed the main goal of its mid-stage trial, and the Miami biotech is now fighting to stay alive. With about $10.1 million in cash at the end of June, the company announced a strategic review and cost-cutting plan.
Updated Sep 17
Approved Lisraya after Priority Review and Orphan Drug Designation
The FDA approved Lisraya on August 27, 2026, clearing the first targeted therapy ever approved for dermatomyositis, a rare autoimmune disease that inflames skin and weakens muscles. The once-daily pill is now on sale in the US.
Updated Sep 16
Approved Isembyld on September 11, 2026
Patients with spinal muscular atrophy (SMA) have had drugs that keep motor neurons alive for a decade. None stopped the muscle wasting that defines advanced disease. On September 11, 2026, the FDA approved the first treatment built to do that.
Granted 510(k) clearance for ZBPro Diagnostic v2.0 (K261580)
A year ago, ZBeats' FDA-cleared software could analyze only 24- and 48-hour Holter recordings from specific electrode setups. On September 15, the company announced a new clearance letting the same cloud platform handle anything from a one-minute snapshot to 14 days of data, including wearable patches.
Regulator deciding whether LSD becomes an approved medicine
A single dose of LSD has beaten placebo in two late-stage anxiety trials. The tablet, which dissolves under the tongue, cut anxiety scores within two days and held the benefit for 12 weeks. Definium announced the second win on September 14, 2026.
Approved Pixclara after an initial Complete Response Letter
Brain cancer doctors face a maddening problem: after radiation and chemo, standard MRI scans often can't tell whether a suspicious spot is tumor regrowth or treatment-related change. The two scenarios call for opposite treatments. The FDA just approved a test that settles the question.
Updated Sep 15
Overseeing the Connect-One early feasibility study
A Michigan woman with motor neuron disease recently called her grandchildren. She didn't use her voice — a brain implant decoded her intended words and spoke them through a synthesizer. Her first freely chosen sentence: "Okay, I have a lot to say."
Updated Sep 14
Approved Zanvastro
Jenny Pearson's daughter Elise had her first seizure at 16 months. A scan a year later showed white splotches on her frontal lobe, and a genetic test confirmed Alexander disease, a rare progressive neurological disorder that had no treatment.
Updated Sep 13
Reviewing the zanzalintinib new drug application
Exelixis learned on September 10 that the FDA would delay its decision on zanzalintinib, its experimental colorectal cancer drug, by three months. The new deadline is March 3, 2027, after the agency deemed updated safety and efficacy data a major amendment to the application.
Updated Sep 11
Granted final approval to OMCAZIO
The FDA cleared a Taiwanese drugmaker to sell an alternate-salt version of the $2.1 billion cancer drug cabozantinib in the United States. The final approval lands three days after a federal appeals court kept generic entry shut by upholding patents on the originator's salt form.
Partial clinical hold in effect since Sept 4, 2026
Nine days after Biohaven signed a licensing deal worth up to $795 million with SK Biopharmaceuticals for its epilepsy drug platform, the FDA halted new enrollment in the drug's two late-stage trials. The hold came not because BHV-7000 (opakalim) showed safety problems in humans—over 1,200 people have taken it and tolerability has been generally clean—but because a metabolite found in rat studies raised questions the agency couldn't fully assess. Biohaven says the finding's significance to people is uncertain and may be rodent-specific.
Updated Sep 10
Reviewing tozorakimab BLA under Priority Review
Millions of COPD patients who don't respond to current biologic treatments may soon have a new option. AstraZeneca's tozorakimab cut moderate-to-severe flare-ups by 29% to 34% in two late-stage trials, and unlike existing biologics, it worked across all blood eosinophil levels.
Cleared TactiFlex Duo for commercial use
The Food and Drug Administration cleared Abbott's TactiFlex Duo, the first U.S. ablation catheter to combine pulsed field and radiofrequency energy. The device is designed for complex atrial fibrillation, a condition affecting about 10.5 million Americans.
Granted accelerated approval to Etcamah on September 4, 2026
The Food and Drug Administration approved AstraZeneca's pill Etcamah (camizestrant) on September 4, 2026, for people with metastatic breast cancer whose tumors carry an estrogen receptor-1 (ESR1) mutation. It is the first cancer therapy approved based on a resistance mutation found in blood before scans show the disease has progressed.
Updated Sep 9
Classified Infinion CX lead recall as Class I
Boston Scientific pulled unused spinal cord stimulator leads from the market after the FDA linked them to more than 1,000 serious injuries. The Infinion CX lead, which delivers electrical pulses to mask chronic pain, can fracture where it anchors to the spine.
Updated Sep 8
Cleared RESTORE trial; approved Expanded Access for individual patients
Tim Andrews went 271 days without dialysis after receiving a genetically engineered pig kidney in January 2025. In January 2026, he received a human donor kidney — the first time a pig organ has bridged a patient to a human transplant.
Updated Sep 7
Granted breakthrough designations to Cognita CXR and Aidoc First Read; seeking input on generative AI device regulation
The Food and Drug Administration granted breakthrough-device status to Cognita CXR, a generative AI model that reads chest X-rays and drafts the preliminary report a radiologist then reviews. It's the first generative model in radiology to get the designation; Aidoc's rival tool, First Read, followed in June.
Updated Sep 6
Cleared Heartvue.Proton via 510(k) with PCCP
Reading a cardiac MRI by hand can take an hour. The FDA just cleared software that automates most of that work, and it comes with permission to keep improving itself.
Updated Sep 5
Issued early alerts; classified June 2025 recall as Class I
The Bravo CF device attaches a pH-monitoring capsule to the esophagus so doctors can diagnose acid reflux. In 761 reported instances since early 2025, the capsule failed to attach or detach as intended, and 184 of those involved serious injuries.
Updated Sep 4
Monitoring the recall, issued Early Alert
Boston Scientific told hospitals to stop using every Imager II Angiographic Catheter it has sold. The tips were made with too little stabilizing agent, which raises the risk they could degrade and detach inside a patient's blood vessel.
Updated Sep 3
Granted De Novo authorization to SportSuite Vision on July 17, 2026
An orthopedic surgeon at Duke Health performed a hip arthroscopy (keyhole surgery on the hip joint) while wearing Apple's Vision Pro headset. Stryker's SportSuite Vision software showed him the arthroscope's live video, computed tomography (CT) scans, and surgical analysis tools floating beside the patient.
Updated Sep 1
Approved Mimrylo under priority review
Polycythemia vera has been treated with bloodletting for more than a century. On August 28, the FDA approved Mimrylo (rusfertide), the first drug mimicking hepcidin, the hormone that limits iron for red blood cell production.
Licensed Ezplaz, the first US freeze-dried plasma
For decades, US plasma transfusions required a freezer and time to thaw. Ezplaz, the first US-licensed freeze-dried plasma, reconstitutes in about 2.5 minutes and sits on a shelf for a year.
Sets drug labels and approves new uses
The FDA approved tirzepatide (Mounjaro) on August 28 to lower the risk of heart attack, stroke, and cardiovascular death in adults with type 2 diabetes at high risk. The decision rests on SURPASS-CVOT, a 13,000-patient trial that found tirzepatide matched an older GLP-1 medicine, dulaglutide (Trulicity), on major heart events, with an estimated 8% lower rate.
Updated Aug 29
Approved Bixlenvo on August 27, 2026
Roughly 5% of Americans living with HIV take their antiretrovirals as several pills a day, because resistance, side effects, or other medications rule out standard single tablets. On Thursday the FDA approved a pill built for that group.
Updated Aug 27
Regulatory authority that authorized the device
The FDA on August 25 authorized Abbott's Libre Duo 10 Day, the first wearable that continuously tracks both blood sugar and ketone levels in a single sensor. The device samples the fluid just beneath the skin every minute for up to 10 days, for people as young as 2.
Updated Aug 26
Authorized Aletta through the De Novo pathway
A robot can now draw your blood. The FDA cleared Aletta on August 19, the first standalone device that finds a vein and takes a sample without a person guiding the needle.
Updated Aug 24
Granted accelerated approval; requires confirmatory data
People with Glycogen Storage Disease Type Ia can't safely go without food. Their bodies can't release stored sugar, so many eat raw cornstarch around the clock, including overnight, to keep blood sugar from crashing. On August 19, 2026, the FDA approved GENGLYCOS, the first treatment aimed at the genetic cause of the disease rather than its symptoms.
Updated Aug 20
Will review Pfizer's Biologics License Application for the Lyme vaccine in 2026-2027
The vaccine, now formally designated PF-07307405 (also called LB6V, and previously known as VLA15), cleared its first regulatory hurdle since March's Phase 3 results. On August 14, 2026, the European Medicines Agency validated Pfizer and Valneva's marketing application, meaning the dossier is complete and formal review can begin.
Updated Aug 15
Granted breakthrough status; will decide on final clearance later
Today, catching lung cancer early usually means a CT scan of your chest. Fewer than one in five people who qualify actually get one. On August 12, 2026, the FDA gave Freenome's blood test for lung cancer a status meant to speed its review, betting that a simple blood draw could reach the millions who skip the scan.
Updated Aug 13
Reviewing denecimig's application
People with hemophilia A can bleed for hours from a small cut and bleed inside their joints for no clear reason. Novo Nordisk says its experimental injection, denecimig, kept most patients bleed-free in a long-term trial: about 71% of adults and teens and about 89% of children had zero treated bleeds.
Updated Aug 11
Reviewing MoonLake's upcoming filing
MoonLake's experimental drug sonelokimab hit its main goal in a second late-stage trial, this time in psoriatic arthritis. The win moves the small Swiss biotech's Nanobody drug closer to two separate markets.
Updated Aug 10
Issued the order clearing bemotrizinol
For more than 25 years, US sunscreen makers worked from the same short list of ultraviolet filters. On August 9, 2026, an FDA order let them start using a new one.
Updated Aug 9
Will decide any U.S. approval for the pill
For most of medical history, vitiligo had no fix. Doctors could sometimes slow the spreading white patches, but regrowing lost skin color was mostly out of reach.
Updated Aug 5
Oversees the trial; would review any approval filing
Norovirus makes about 20 million Americans sick each year, and no vaccine has ever been approved to stop it. Moderna's shot is the furthest along. On July 31, 2026, the company said that shot fell short of the bar for early success in its big trial.
Updated Jul 31
Reviewing the expanded use under priority review
About one in four men with advanced prostate cancer carry inherited flaws in the genes that repair damaged DNA. A large trial now shows that giving those men a targeted pill alongside standard hormone therapy delays the cancer's spread by a wide margin.
Updated Jul 30
Holds the approval pathway for SDF as a cavity drug
Every year, untreated tooth decay sends thousands of small U.S. children to emergency rooms, and fixing a cavity in a toddler often means a drill, a needle, or sedation. A new University of Michigan trial points to a simpler option: a liquid brushed onto the tooth in seconds.
Approved XOCOVA for post-exposure prevention
For years, the only move after a close COVID-19 exposure was to wait and watch for symptoms. Now there is a pill for that.
Updated Jul 29
Reviewed and approved Lipfendra
For a decade, the most powerful cholesterol drugs came only as shots. On July 16, 2026, the FDA approved Merck's Lipfendra, a once-daily pill that cut LDL cholesterol about as much as those injections did.
Updated Jul 16
Regulator reviewing DF-003's path to market
A few dozen families worldwide carry a gene mutation that slowly steals their sight and floods their bodies with inflammation. On July 13, 2026, Drug Farm announced it raised $55 million to push its candidate for that disease, ROSAH syndrome, into a Phase 3 trial.
Updated Jul 14
Developing cancer vaccine regulatory framework
Metastatic breast cancer typically kills most patients within five years. A small group of women vaccinated in a Duke University clinical trial two decades ago have defied that prognosis entirely; all remain alive today. Researchers found these survivors still carry specialized immune cells that recognize their cancer, offering a model for why some therapeutic vaccines produce lasting results.
Updated Jul 9
Approved six CAR-T therapies; removed REMS requirements in 2025
Gene therapy killed Jesse Gelsinger in 1999. His death triggered FDA shutdowns and nearly ended the field.
Updated Jul 3
Regulator that granted the approval
More than 8 in 10 donor lungs recovered from deceased donors never reach a patient. On June 29, 2026, the FDA approved a device built to change that math. United Therapeutics won premarket approval for LungFX, a system that keeps donor lungs warm, ventilated, and pumped with fluid outside the body so transplant teams can re-examine organs they had already rejected.
Updated Jun 29
Granted both first-line approvals
Triple-negative breast cancer is aggressive and short on options. On June 24, 2026, the U.S. Food and Drug Administration cleared Gilead Sciences' Trodelvy as a first-line treatment, moving a drug once used only after other therapies failed to the front of the line. Six days earlier, the European Commission had done the same for patients in the EU who are ineligible for immunotherapy.
Updated Jun 25
Primary regulator of AI medical devices in the United States
University of Michigan researchers published Prima in February 2026, an AI that reads brain MRIs in seconds with up to 97.5% accuracy across 50 neurological conditions. In April 2026, Harvard Medical School reported that OpenAI's o1 model correctly diagnosed emergency patients 67% of the time, compared to 50–55% for two attending physicians reviewing the same cases.
Updated Jun 24
Approved Colorado's program; oversees state imports
On June 15, 2026, the FDA approved Colorado's plan to import about 20 prescription medicines from Canada. The state estimates residents will save 20% to 70% on those drugs, totaling roughly $46 million over three years.
Updated Jun 16
Granted the approval
Surgery removes the tumor. For many high-risk kidney cancer patients, it doesn't end the disease. On June 12, 2026, the U.S. Food and Drug Administration (FDA) approved pairing belzutifan with the immunotherapy pembrolizumab to keep these patients cancer-free for longer after their kidney is removed.
Updated Jun 12
Reviewing darovasertib through its Real-time Oncology Review program
IDEAYA Biosciences closed a $323.6 million stock sale on June 10, 2026. The cash lands as the company prepares to file its first drug with the U.S. Food and Drug Administration (FDA).
Updated Jun 10
Granted Breakthrough Therapy Designation
Some children with spinal muscular atrophy get a one-time gene therapy, then slowly weaken again. There has been no clear next step for them. On June 4, 2026, the FDA gave Biogen's salanersen a designation meant to speed up that next step.
Updated Jun 4
Granted approval; previously designated Optune Pax as Breakthrough Device in December 2024
Pancreatic cancer kills roughly 52,000 Americans each year and carries a five-year survival rate of 13 percent. In February 2026, the FDA approved Optune Pax, the first new treatment for locally advanced disease in nearly 30 years, adding alternating electric fields to the treatment options alongside chemotherapy.
Updated Jun 3
Has granted Breakthrough Device Designation to multiple decongestion devices
A catheter threaded into a vein in the neck pulled an average 6.8 kilograms of excess fluid out of 40 hospitalized heart failure patients without damaging their kidneys. Six months later, 82.5 percent were still alive and out of the hospital.
Updated May 31
Reviewing mRNA-1010 with August 5, 2026 decision deadline
For 80 years, flu vaccines grew in chicken eggs — a process effective against roughly 40% of infections in good years. On May 8, the New England Journal of Medicine published Moderna's Phase 3 data: mRNA-1010 reduced influenza illness by 26.6% more than a standard shot in 40,805 adults aged 50 and older. Moderna's stock rose 16% that day.
Granted approval
Patients with advanced bile duct cancer driven by a rare genetic fusion called NRG1 had nothing approved for them after chemotherapy failed. On May 8, the FDA approved Bizengri (zenocutuzumab-zbco) from Partner Therapeutics as the first drug targeting this NRG1 fusion, blocking the abnormal protein it produces, which fuels tumor growth.
Reviewing safety and efficacy of next-generation candidates
Boys born with Duchenne muscular dystrophy typically lose the ability to walk before their teens and rarely live past 30. The first drugs designed to slow that decline reached the market in 2016, but they restore less than 1% of normal dystrophin, the muscle protein patients are missing. A decade later, a new wave of biotech companies is trying to deliver far more of that protein into muscle cells using engineered molecular shuttles.
Approved supplemental application expanding ASCENIV's pediatric indication
For seven years, an immune therapy made from antibody-rich human plasma was available only to teenagers and adults. On May 4, 2026, the FDA extended ADMA's ASCENIV to children as young as two, ending the reliance on off-label or alternatives.
Pre-NDA meeting with Mirum scheduled for summer 2026
For the roughly 30,000 Americans living with primary sclerosing cholangitis (PSC), the U.S. Food and Drug Administration has never approved a single drug. On May 4, 2026, Mirum Pharmaceuticals reported that its experimental pill volixibat hit the primary endpoint of its Phase 2b VISTAS trial, reducing the relentless itch far more than placebo.
Approved first-in-class PROTAC 35 days early
For 25 years, drug companies have tried to design medicines that destroy harmful proteins outright rather than blocking them. On May 1, the U.S. Food and Drug Administration (FDA) approved the first one.
Approved Lerochol (December 2025); evaluating enlicitide decanoate as potential first oral PCSK9 inhibitor
For two decades, lowering LDL cholesterol meant statins—daily pills that work for most but leave roughly one in five patients with muscle pain or liver enzyme changes severe enough to quit. On May 1, researchers from the University of Barcelona and Oregon Health & Science University reported that engineered DNA reduced LDL by nearly 50 percent in mice. A single injection of this engineered DNA molecule silences the gene controlling how the liver clears LDL.
Issued approval on PDUFA action date
Until May 2023, no drug was approved in the United States to treat the agitation that affects up to three-quarters of people with Alzheimer's disease. Doctors reached for antipsychotics off-label, a class of medicines that carries a black-box warning for increased death risk in older dementia patients. On April 30, 2026, the FDA approved Axsome Therapeutics' Auvelity for the indication, doubling approved options from one to two. The FDA called it the 'first non-antipsychotic drug to treat agitation associated with dementia' — what sets it apart from Rexulti.
Receiving rolling BLA submission for lonvo-z under RMAT designation; full submission expected H2 2026
On April 27, 2026, Intellia Therapeutics reported results from Phase 3 testing of lonvoguran ziclumeran (lonvo-z), a one-time in-body CRISPR gene-editing therapy for hereditary angioedema. The 80-patient randomized double-blind trial found a single IV infusion cut debilitating swelling attack rates by 87% versus placebo (weeks 5-28); 62% of patients became attack-free and stopped all preventive medications. The safety profile was clean: no serious adverse events, and infusion-related reactions, headache, and fatigue—the most common complaints—were mild or moderate.
Co-issuing RAPID pathway
For nearly a decade, medical device makers have faced the same bottleneck: the FDA clears a breakthrough device, and then Medicare spends another year or more deciding whether to pay for it. On April 23, 2026, the two agencies jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway — it cuts that timeline to as little as two months. They simultaneously paused the existing Transitional Coverage for Emerging Technologies (TCET) program for new applicants, consolidating all breakthrough-device coverage work under RAPID.
Responding to executive order: issuing priority review vouchers for psilocybin-class drugs and clearing path for first US ibogaine trials
For 55 years, the federal government classified psilocybin, MDMA, LSD, and ibogaine as Schedule I substances. On April 18, 2026, President Trump signed an executive order 'Accelerating Medical Treatments for Serious Mental Illness' directing the FDA to expedite clinical trials of those substances for PTSD in veterans.
Granted traditional approval to tarlatamab in November 2025
For decades, patients with extensive-stage small-cell lung cancer who relapsed after chemotherapy had almost nowhere to turn — five-year survival rates sat around 3%. Now a drug that bridges the patient's immune cells to their tumor has won approval in both the United States and China.
Cleared the first human trial of epigenetic reprogramming therapy
In 2006, Shinya Yamanaka showed that four genes could rewind an adult cell all the way back to an embryonic-like state. Twenty years later, a stripped-down version of that technique is being injected into human eyes for the first time.
Updated May 30
Approved Foundayo under new fast-track voucher program
For two years, the most effective weight-loss drugs on the market required a weekly injection, but that barrier is now falling. Eli Lilly began shipping Foundayo on April 6, 2026 — just five days after FDA approval in a record 50-day review — making it the first oral GLP-1 pill with no food or water restrictions. At $149/month (or $25 with insurance), it's 85% cheaper than injectables.
Granted RMAT designation to CB-011
Every approved cancer cell therapy today requires extracting a patient's own cells, engineering them in a lab, and infusing them back. It costs over $400,000 and sometimes takes weeks — long enough that patients' cancer can grow while they wait.
Reviewing relutrigine NDA under priority review
Children with SCN2A and SCN8A developmental and epileptic encephalopathies have never had a drug designed for their condition, cycling through four or more unapproved medications as seizures persist and development regresses. The FDA accepted Praxis Precision Medicines' application for relutrigine and granted priority review, with a decision expected by September 27, 2026.
Approved Awiqli after initially issuing rejection in 2024
For 104 years, every insulin on the market has required at least one injection per day. On March 26, the FDA approved Awiqli, a once-weekly basal insulin from Novo Nordisk for adults with type 2 diabetes. That cuts basal insulin injections from 365 to 52 per year.
Overseeing GLP-1 post-market safety surveillance
More than 30 million Americans now take GLP-1 receptor agonist drugs like Ozempic and Wegovy to lose weight. A persistent concern has dogged the medications since their rise: that they burn through muscle along with fat, leaving patients weaker even as they get thinner.
Granted accelerated approval to AVLAYAH
For decades, the blood-brain barrier has blocked nearly all large-molecule drugs from reaching the brain — a biological wall that left most neurological diseases effectively untreatable with modern biologics. On March 25, 2026, the FDA approved Denali Therapeutics' AVLAYAH. It's the first drug specifically engineered to cross the blood-brain barrier and deliver a therapeutic enzyme to the central nervous system after a simple intravenous infusion.
Granted expanded indication for OmniaSecure
For decades, defibrillators have saved lives by shocking dangerously fast rhythms back to normal, but the leads also pace the heart unnaturally and can cause damage over time. Medtronic's OmniaSecure lead is the first defibrillation lead that can pace through the heart's own electrical wiring, closely mimicking natural heartbeats. It has been cleared by the FDA for placement in the left bundle branch area.
Removed psychiatric risk warnings from GLP-1 labels in January 2026
Drugs originally designed to control blood sugar and reduce weight may also protect the brain. A study of 95,490 people in Sweden, published in The Lancet Psychiatry on March 22, 2026, found that semaglutide (the compound in Ozempic and Wegovy) reduced psychiatric hospitalizations, worsening depression, and substance-use crises.
Approves fourth obesity drug in 13 months: Imcivree (rare), high-dose Wegovy, oral semaglutide, and Foundayo (common)
For the first time, patients with acquired hypothalamic obesity have an FDA-approved treatment. On March 19, 2026, the FDA approved Imcivree (setmelanotide), which targets this rare condition affecting roughly 10,000 Americans whose hypothalamic damage from brain tumor surgery makes diet and exercise ineffective.
Approved ICOTYDE for moderate-to-severe plaque psoriasis
For two decades, treating moderate-to-severe psoriasis required needles — self-injected drugs or clinic infusions many patients refused or abandoned. On March 18, 2026, the FDA approved ICOTYDE, a once-daily pill that blocks the IL-23 receptor like injectable biologics. In trials of roughly 2,500 patients, about 70 percent achieved clear or almost clear skin at 16 weeks, with side effects within 1.1 percentage points of placebo.
Reviewing antibiotic candidates under expedited pathways
No genuinely new class of antibiotic has reached patients since 1987, and in the nearly four decades since, bacteria have steadily evolved resistance to existing drugs. Carbapenem-resistant Acinetobacter baumannii—a hospital-acquired pathogen that kills up to 60 percent of ventilated pneumonia patients—is at the top of the WHO's list of critical-priority threats. On March 16, 2026, Swiss biotech BioVersys received FDA clearance to enroll American patients in a Phase 3 pivotal trial of BV100, which reduced 28-day mortality by half in earlier testing.
Approved PureSee without contrast sensitivity warning based on clinical data
For a decade, patients choosing premium lenses during cataract surgery have faced a trade-off: better vision range, but dimmer, lower-contrast sight—especially in low light. On March 12, 2026, the FDA approved Johnson & Johnson's TECNIS PureSee, the first extended depth of focus lens cleared in the U.S. without a contrast sensitivity warning.
Approved leucovorin for rare condition; declined autism indication
In September 2025, White House officials told parents of autistic children that a cheap, generic drug called leucovorin might improve their children's speech and behavior. Prescriptions surged 71% in the following months, pharmacies ran dry, and the Food and Drug Administration (FDA) allowed emergency imports from Canada and Spain. On March 10, 2026, the FDA approved leucovorin — but only for a genetic condition so rare that fewer than 50 cases have ever been identified worldwide, not for autism.
Granted accelerated approval for Ojemda; confirmatory Phase 3 trial ongoing
For decades, children with relapsed brain tumors had no approved targeted treatment. That changed in April 2024 when the FDA cleared Ojemda, a once-weekly pill for pediatric low-grade glioma, the most common childhood brain cancer. Day One Biopharmaceuticals, the company behind it, has agreed to be acquired by France's Servier for $2.5 billion in cash—a 68% premium over its previous closing share price.
Reached PDUFA decision deadline on Sotyktu for psoriatic arthritis
For most of the past decade, people with psoriatic arthritis who wanted a pill had one real choice: Janus kinase (JAK) inhibitors. The FDA slapped those drugs with its strongest safety warning in 2021, after a major trial linked them to higher rates of heart attacks, blood clots, cancer, and death.
Granted Breakthrough Therapy Designation to zorevunersen
Dravet syndrome is a severe genetic epilepsy that causes hundreds of seizures per month, cognitive decline, and a 15–20 percent mortality rate. For nearly five decades, no treatment addressed the underlying cause — including two drugs approved in the past eight years, which could only partially suppress symptoms.
Developing framework for generative AI medical devices
The FDA has cleared more than 1,250 artificial intelligence-enabled medical devices — nearly all narrow systems that read scans or flag anomalies without talking to patients. On March 3, 2026, RecovryAI announced that its Virtual Care Assistants were granted Breakthrough Device Designation, the first patient-facing generative large language model product to enter the FDA's accelerated review pipeline.
Has approved Dupixent nine times across distinct indications
Dupixent was approved for severe eczema in 2017 as a one-disease drug. Nine years later, it's approved for nine conditions, with the latest approval (February 24, 2026) covering allergic fungal rhinosinusitis (AFRS) — which previously had no approved treatment — and reducing the need for additional surgeries and steroid courses by 92% in trials.
Updated May 29
Issued draft guidance creating the plausible mechanism framework
For decades, the FDA required all drugs to prove effectiveness through controlled trials with sufficient sample sizes, a standard that made sense for common diseases but created an impossible barrier for ultra-rare conditions. On February 23, 2026, the FDA issued draft guidance for a new standard—the 'plausible mechanism' framework. Developers of gene-editing and ribonucleic acid (RNA) therapies could win full approval by showing that their treatment targets the root genetic cause, engages it, and improves outcomes compared to the disease's natural course.
Continuing active review of psychiatric drug applications
The FDA approved Cobenfy for schizophrenia in September 2024—the first drug to treat the condition through muscarinic receptors rather than dopamine, a different approach than any approved in the previous 50 years. Bysanti (milsaperidone) followed in February 2026, cleared for both schizophrenia and bipolar I disorder. For the roughly 7 million Americans with these conditions, the treatment menu is wider than it was two years ago.
Approved the venetoclax-acalabrutinib combination
On February 20, 2026, the FDA approved venetoclax and acalabrutinib for chronic lymphocytic leukemia (CLL), the most common adult leukemia in Western countries, with roughly 23,000 new American cases each year. In a trial of 867 patients, 77% remained cancer-free at three years.
Implementing three-pronged domestic manufacturing incentive strategy
Only 9% of the factories making active pharmaceutical ingredients for American medicines are in the U.S.; China and India account for roughly two-thirds. For decades, this arrangement kept drug prices low and went largely unchallenged, until the COVID-19 pandemic exposed how quickly a foreign export ban could empty American pharmacy shelves. The FDA is assembling three programs to reverse this dependency: PreCheck to accelerate new factory buildouts, priority reviews for domestically made generics, and a proposed three-year fee waiver for new domestic plants under the next Generic Drug User Fee Amendments (GDUFA) reauthorization.
Undergoing significant regulatory changes under new leadership
For 63 years, the FDA required drugmakers to prove their products worked in at least two rigorous clinical trials. On February 18, 2026, Commissioner Marty Makary formally ended that standard. Now one trial is the 'default position' for all new drugs—from rare diseases to common conditions affecting millions of patients. In accompanying articles published in the New England Journal of Medicine and JAMA, Makary and Deputy Commissioner Vinay Prasad emphasized that the single-trial standard doesn't eliminate evidence requirements. Instead, sponsors must provide 'confirmative evidence' through mechanistic data, findings from related indications, animal models, real-world evidence, or data from drugs in the same class.
Regulator of medical devices including bone grafts
Medtronic's INFUSE bone graft has spent 24 years navigating FDA approval, off-label controversy, and lawsuits. The FDA just approved INFUSE for transforaminal lumbar interbody fusion (TLIF) procedures—the only growth factor bone graft approved for two-level spinal constructs and the only one cleared for anterior, oblique, and transforaminal approaches.
Supporting transition from animal testing to alternative models
For the first time, scientists have grown a miniature human spinal cord in a laboratory, injured it, and watched it heal. Northwestern University researchers published findings in Nature Biomedical Engineering showing their organoid replicates cell death, inflammation, and scarring in spinal cord injuries and shows tissue repair when treated with an experimental therapy.
Faces pressure to revise statin labels
More than 200 million people worldwide take statins for heart health. For decades, package inserts have warned about 66 potential side effects, from memory loss to depression to muscle pain. The February 2026 Lancet analysis of 23 major clinical trials with nearly 155,000 participants found 62 of those warnings unsupported by evidence, with symptoms appearing equally in statin and placebo groups.
Approved three achondroplasia treatments: Voxzogo (daily), YUVIWEL (weekly), reviewing BridgeBio filing
About 250,000 people worldwide have achondroplasia, the most common genetic cause of dwarfism. Until BioMarin's Voxzogo, the only approved treatment required daily injections.
January 2026 wellness guidance allows blood pressure estimation without clearance; cardiologists publicly raising accuracy concerns
Oura's fifth-generation smart ring went on sale Thursday with blood pressure monitoring and on-demand telehealth access, starting at $399. The Ring 5 is 40% smaller than its predecessor and monitors nighttime blood pressure shifts that can warn of cardiovascular strain.
Approving agency for Decnupaz
The FDA approved AbbVie's Decnupaz on May 27 for blastic plasmacytoid dendritic cell neoplasm, an aggressive blood cancer. It strikes an estimated few hundred Americans a year. It's the second drug ever approved for the disease and the first doctors can start in an outpatient clinic.
Updated May 28
Adapting approval pathways for AI-driven precision medicine
For decades, cancer drug trials have failed at a rate exceeding 95%, burning through $50–60 billion annually on treatments tested in patients unlikely to respond. On April 17, 2025, researchers from AstraZeneca and Tempus AI published in Cancer Cell results from the Predictive Biomarker Modeling Framework, a machine learning system using contrastive learning on existing clinical data. The system can identify which cancer patients will survive longer on immunotherapy versus chemotherapy. Applied retrospectively to completed phase 3 trials, it improved survival outcomes by 15% compared to traditional patient selection.
Updated May 27
Accepted Helix pre-submission for substantive review; Q2 2026 meeting scheduled; reviewing CardiAMP accelerated approval request
In March 2026, the FDA accepted BioCardia's pre-submission package for the Helix Transendocardial Delivery Catheter, the first catheter that injects cell and gene therapies directly into heart muscle, and scheduled a formal meeting for Q2 2026. The device, backed by fifteen clinical trials, uses a small helical needle anchored within the beating heart to precisely deliver therapeutic agents to damaged tissue; CDRH leads the review in consultation with CBER.
Evaluating rilzabrutinib under breakthrough therapy pathway
For 50,000 Americans with warm autoimmune hemolytic anemia, there's never been a disease-specific treatment. On February 9, 2026, the FDA granted breakthrough therapy designation to rilzabrutinib—the first BTK inhibitor to reach this milestone for the condition—signaling it may offer substantial improvement over existing therapies.
Approved suzetrigine for moderate-to-severe acute pain
For more than 20 years, doctors facing patients in severe pain had two choices: prescribe opioids that risked addiction, or use weaker alternatives that often fell short. On January 30, 2025, the Food and Drug Administration (FDA) approved suzetrigine—brand name Journavx—ending that drought as the first entirely new class of pain medication since the late 1990s.
Granted breakthrough device designations and approved first non-invasive spinal cord stimulator
Blood pressure instability has long burdened people with spinal cord injuries. Among those with cervical injuries, 78% experience dangerous drops when sitting upright, yet only 28% receive effective treatment. ONWARD Medical just enrolled the first participant in a trial testing whether an implanted spinal cord stimulator can restore the autonomic signals that paralysis disrupts.
Updated May 26
Approving new breast cancer treatments at accelerated pace
The U.S. breast cancer death rate has fallen 44% since its 1989 peak—an estimated 546,000 lives saved. Susan G. Komen's 2026 Progress Outlook attributes three-quarters of this decline to treatment advances and the remainder to earlier detection through mammography screening.
Regulatory decision triggered underlying dispute
Delaware's courts rule on American corporate disputes. On January 12, 2026, the state's Supreme Court decided that when a merger agreement specifies a particular path to an earnout payment, courts won't rescue sellers who failed to negotiate alternatives.
Overseeing Neuralink's U.S. trials
Two years ago, Neuralink implanted a coin-sized chip in Noland Arbaugh's brain—the first human to receive the company's Telepathy device. As of January 28, 2026, twenty-one people across four countries use Neuralink implants to control computers, phones, and robotic arms with their thoughts; several now exceed the cursor-control speed of able-bodied people using a mouse.
Reviewing Anaphylm NDA with January 31, 2026 target date
For nearly four decades, Americans facing life-threatening allergic reactions had exactly one option: stab themselves with a needle. The EpiPen and its competitors delivered epinephrine effectively, but needle phobia kept roughly 30% of patients from using their prescribed devices during emergencies—contributing to preventable deaths. Now the needle era is ending.
Updated May 23
Approved YUVEZZI as fourth presbyopia eye drop
For 240 years, reading glasses have treated presbyopia—the gradual loss of near vision that affects nearly everyone over 45—unchanged since Benjamin Franklin invented bifocals in 1785. Two billion people worldwide still rely on reading glasses today. On January 29, 2026, the FDA approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution), the first dual-agent eye drop for presbyopia.
Approved Yartemlea after extended review process
For decades, patients with transplant-associated thrombotic microangiopathy (TA-TMA) after stem cell transplants faced no FDA-approved treatment—mortality rates reached 80-90% for severe cases. In December 2025, the FDA approved Yartemlea, the first therapy for TA-TMA.
Cancer vaccines have promised to train the immune system against tumors for decades. None has delivered a durable, replicable benefit until now.
Updated May 22
Reviewing NXC-201; will rule on eventual Biologics License Application
Immix Biopharma reported Thursday that 19 of 20 patients in its NEXICART-2 Phase 2 trial reached complete remission with NXC-201, a one-time CAR-T cell therapy for AL amyloidosis. The 95% complete response rate is up from 75% in an earlier readout, and all four patients with minimal-residual-disease-negative status have now converted to complete responses.
Updated May 21
Reviewing sparsentan sNDA with new April 13, 2026 PDUFA date
No FDA-approved treatment for focal segmental glomerulosclerosis (FSGS) has ever existed. For the 40,000 Americans with this rare kidney disease—which drives half to kidney failure within a decade—the only options have been off-label immunosuppressants with mixed results.
Approved generic CF drugs after patent expiration
A generic version of Trikafta—the cystic fibrosis drug that extends lives by decades—hit the market at $12,750 per year. That's 95% cheaper than Vertex Pharmaceuticals' brand-name version, which costs over $300,000 annually. The brand-name drug has generated billions while remaining out of reach for patients in developing nations and many Americans with inadequate insurance.
Updated May 20
Approved Guardant360 Liquid CDx on May 20, 2026
For most patients with advanced cancer, picking the right targeted drug still starts with a tissue biopsy. On May 20, the FDA approved a blood test that reads 100 times more of the tumor's DNA than the previous version.
Developing joint CDER-CBER guidance on plausible mechanism pathway
In August 2024, KJ Muldoon was born with a death sentence encoded in his DNA—a single broken letter among three billion that left his body unable to process protein. Six months later, he walked out of Children's Hospital of Philadelphia, cured by a gene-editing therapy designed, manufactured, approved, and delivered in 180 days.
Updated May 19
Granted Breakthrough Therapy Designation to TERN-701
Merck borrowed billions in the investment-grade bond market on Monday. The cash refinances its $6.7 billion all-cash purchase of Terns Pharmaceuticals, a small California biotech the company closed on two weeks ago.
Updated May 18
Approved both new indications; also cleared companion diagnostic tests
The U.S. Food and Drug Administration (FDA) cleared AstraZeneca and Daiichi Sankyo's Enhertu for two new uses in early-stage HER2-positive breast cancer in May 2026. The drug, already a standard for advanced disease, now enters the window where the goal is cure, not control.
Future regulator for zasocitinib’s NDA; the main gatekeeper for U.S. commercialization
Psoriasis has been an injectable kingdom for years: shots that work great, pills that usually don't. Takeda's once-daily TYK2 pill zasocitinib just cleared Phase 3 topline hurdles—and by the next session investors responded, sending Takeda shares up as much as 4.3% in early Tokyo trading (a seven-month-high intraday jump).
Updated May 15
Defendant; defending 2021 rule changes
The Supreme Court has until Thursday at 5 p.m. ET to decide whether mifepristone can keep shipping by mail. Alito's May 14 stay is all that blocks a May 1 Fifth Circuit ruling ending telehealth mifepristone prescribing and mail delivery nationwide.
Updated May 13
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