U.S. Food and Drug Administration

The federal agency responsible for evaluating and approving drugs in the United States; has granted Dupixent Priority Review designation for multiple indications including COPD and AFRS. - Has approved Dupixent nine times across distinct indications

When the Food and Drug Administration (FDA) approved Dupixent for severe eczema in 2017, it was one drug for one disease. Nine years later, the same molecule has been approved for nine separate conditions, from asthma to a chronic fungal sinus infection that previously had no approved treatment at all. The latest approval, granted on February 24, 2026, covers allergic fungal rhinosinusitis (AFRS), a condition that traps patients in a cycle of repeated sinus surgeries. In a pivotal trial, Dupixent reduced the need for additional surgeries and steroid courses by 92%.

Updated 4 days ago

The United States agency responsible for approving drugs, biologics, and medical devices for public use. - Issued draft guidance creating the plausible mechanism framework

For decades, the Food and Drug Administration (FDA) required the same basic proof for every drug: show it works in a controlled trial with enough patients to be statistically meaningful. That standard made sense for common diseases but created an impossible barrier for conditions affecting a handful of people worldwide. On February 23, 2026, the FDA issued draft guidance creating a fundamentally different standard—called the "plausible mechanism" framework—that would let developers of individualized gene-editing and ribonucleic acid (RNA) therapies win full approval by demonstrating their treatment targets the root genetic cause, successfully edits or engages the target, and improves outcomes compared to the disease's documented natural course.

Updated 5 days ago

The federal agency responsible for evaluating and approving new drugs, including the regulatory pathway that allowed Bysanti's accelerated approval based on existing safety data. - Continuing active review of psychiatric drug applications

Every atypical antipsychotic approved since the early 1990s has worked the same basic way: blocking dopamine receptors in the brain. In the past 17 months, the Food and Drug Administration (FDA) has approved three new psychiatric drugs—including Cobenfy, the first schizophrenia treatment with a genuinely novel mechanism in over 50 years, and now Bysanti, a new chemical entity from Vanda Pharmaceuticals cleared for both bipolar I disorder and schizophrenia. For the roughly 7 million Americans living with these conditions, the options just got meaningfully wider.

Updated 7 days ago

The federal agency responsible for evaluating and approving prescription drugs in the United States. - Approved the venetoclax-acalabrutinib combination

For decades, patients diagnosed with chronic lymphocytic leukemia—the most common adult leukemia in Western countries, affecting roughly 23,000 Americans each year—faced a difficult choice: endure rounds of intravenous chemotherapy with harsh side effects, or take targeted pills indefinitely, sometimes for life. On February 20, 2026, the Food and Drug Administration (FDA) approved a combination of two oral drugs, venetoclax and acalabrutinib, that eliminates both burdens. Patients take pills for roughly one year, then stop. In a trial of 867 patients, 77% remained cancer-free at three years.

Updated Feb 20

The federal agency responsible for approving drugs, inspecting manufacturing facilities, and reviewing generic drug applications — making it the central gatekeeper for any onshoring effort. - Implementing three-pronged domestic manufacturing incentive strategy

Only 9% of the factories that make active pharmaceutical ingredients for American medicines are located in the United States. China and India account for roughly two-thirds of the rest. 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. Now the Food and Drug Administration (FDA) is quietly assembling what amounts to a three-layer incentive stack designed to reverse that dependency: the PreCheck pilot program to accelerate new factory buildouts, a priority review track for generics manufactured entirely on U.S. soil, and a proposed three-year fee waiver for new domestic plants under the next Generic Drug User Fee Amendments (GDUFA) reauthorization.

Updated Feb 20

Federal agency responsible for protecting public health by regulating drugs, medical devices, food, and other products. - Undergoing significant regulatory changes under new leadership

For 63 years, the Food and Drug Administration required drugmakers to prove their products worked in at least two rigorous clinical trials before Americans could take them. On February 18, 2026, Commissioner Marty Makary formally ended that standard, announcing that one trial will now be the "default position" for all new drugs—not just treatments for rare and fatal diseases, but medications for 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 does not 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.

Updated Feb 20

Federal agency responsible for protecting public health through regulation of medical devices, drugs, and biologics. - Regulator of medical devices including bone grafts

For 24 years, Medtronic's INFUSE bone graft has followed a winding path through FDA approval, off-label controversy, lawsuits, and now expansion. The Food and Drug Administration (FDA) just granted INFUSE approval for transforaminal lumbar interbody fusion (TLIF) procedures—making it the only growth factor bone graft approved for two-level spinal constructs and the only one cleared for anterior, oblique, and transforaminal approaches.

Updated Feb 17

Federal agency regulating drugs and medical devices, now actively encouraging organoid-based testing as alternative to animal models. - 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 stem-cell-derived organoid accurately replicates cell death, inflammation, and scar formation seen in real spinal cord injuries—then demonstrated significant tissue repair when treated with an experimental therapy.

Updated Feb 16

Federal agency responsible for approving and regulating prescription drug labels in the United States. - Faces pressure to revise statin labels

More than 200 million people worldwide take statins for heart health. For decades, package inserts have warned them about 66 potential side effects, from memory loss to depression to muscle pain. A new analysis of 23 major clinical trials—the largest ever conducted—found that 62 of those warnings are unsupported by evidence.

Updated Feb 15

Federal agency responsible for approving medical devices and drugs for use in the United States. - Granted approval; previously designated Optune Pax as Breakthrough Device in December 2024

Pancreatic cancer has been oncology's grimmest frontier. The five-year survival rate sits at 13 percent—and for decades, patients diagnosed with locally advanced disease had essentially one option: chemotherapy that extended life by months, not years. On February 11, 2026, that changed. The Food and Drug Administration approved Optune Pax, a portable device that delivers alternating electrical fields to the abdomen, marking the first new FDA-approved treatment for locally advanced pancreatic cancer in nearly three decades.

Updated Feb 13

The FDA has authorized over 1,000 AI-enabled radiology devices, creating regulatory pathways that shape how AI tools reach clinical practice. - Primary regulator of AI medical devices in the United States

Radiologists have spent decades reading brain scans the same way: study the images, cross-reference patient history, dictate findings, move to the next case. A single magnetic resonance imaging (MRI) interpretation can take 20 minutes. Now an artificial intelligence system developed at the University of Michigan can do it in seconds—and flag which patients need emergency intervention before a human ever sees the scan.

Updated Feb 13

The FDA approved the first achondroplasia treatment in 2021 and is now reviewing competitors while evaluating BridgeBio's planned submission. - Reviewing multiple achondroplasia treatments

For the estimated 250,000 people worldwide living with achondroplasia—the most common genetic cause of dwarfism—the only approved treatment has required daily injections. On February 12, 2026, BridgeBio reported that its oral pill achieved a 2.10 cm/year increase in height growth over placebo in a Phase 3 trial, exceeding the 1.57 cm/year gain shown by BioMarin's injectable Voxzogo and marking the first statistically significant improvement in body proportionality ever demonstrated for this condition.

Updated Feb 12

Federal agency responsible for approving drugs and companion diagnostics, increasingly accepting AI-derived biomarkers in regulatory submissions. - 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 who were never likely to respond. On April 17, 2025, researchers from AstraZeneca and Tempus AI published results in Cancer Cell showing that the Predictive Biomarker Modeling Framework (PBMF)—a machine learning system using contrastive learning—can identify, from existing clinical data, which cancer patients will survive longer on immunotherapy versus chemotherapy. Applied retrospectively to completed phase 3 trials, the system improved survival outcomes by 15% compared to traditional patient selection.

Updated Feb 11

The FDA regulates medical devices, drugs, and biologics in the United States, including cell and gene therapies for cardiac disease. - Reviewing BioCardia Pre-Submission

For two decades, scientists have known how to grow cells and engineer genes that could repair damaged hearts. The problem has been getting those therapies to the right spot. On February 10, 2026, BioCardia filed for FDA approval of the Helix catheter—a device that threads through blood vessels to inject treatments directly into heart muscle. If approved, it would be the first system of its kind cleared for use in the United States.

Updated Feb 10

U.S. agency responsible for drug safety and efficacy review, which grants breakthrough therapy designation to drugs showing substantial improvement over existing treatments for serious conditions. - Evaluating rilzabrutinib under breakthrough therapy pathway

For 50,000 Americans living with warm autoimmune hemolytic anemia, there has never been a treatment specifically designed for their disease. On February 9, 2026, the Food and Drug Administration (FDA) granted breakthrough therapy designation to rilzabrutinib—marking the first time a Bruton's tyrosine kinase (BTK) inhibitor has reached this milestone for the condition. The designation signals the FDA's recognition that this drug may offer substantial improvement over existing therapies.

Updated Feb 9

Federal agency responsible for approving new medications and ensuring drug safety in the United States. - 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.

Updated Feb 7

US federal agency responsible for approving drugs and medical devices for market. - 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. The Food and Drug Administration (FDA) approved the first needle-free alternative, a nasal spray called neffy, in August 2024. On February 2, 2026, the FDA issued a Complete Response Letter for Anaphylm, a dissolvable film placed under the tongue, rejecting the application but limiting deficiencies to human factors and packaging rather than safety or efficacy concerns. Aquestive Therapeutics expects to resubmit in the third quarter of 2026 after conducting a redesigned human factors validation study and a supporting pharmacokinetics study.

Updated Feb 5

Federal agency responsible for approving medical devices, whose decision to close the 510(k) pathway for first-generation surgical robots precipitated the earnout dispute. - Regulatory decision triggered underlying dispute

Delaware's courts have long served as the final word on American corporate disputes. On January 12, 2026, the state's Supreme Court issued a ruling that will reshape how companies structure billion-dollar acquisitions: when a merger agreement specifies a particular path to an earnout payment, courts will not rescue sellers who failed to negotiate alternatives.

Updated Feb 4

Federal agency responsible for approving medical devices in the United States, which has granted ONWARD Medical 10 Breakthrough Device Designations. - Granted breakthrough device designations and approved first non-invasive spinal cord stimulator

For decades, blood pressure instability has silently debilitated people with spinal cord injuries—78% of those with cervical injuries experience dangerous drops when sitting upright, yet only 28% receive treatment that actually works. ONWARD Medical just enrolled the first participant in a pivotal trial testing whether an implanted spinal cord stimulator can solve this problem by restoring the autonomic signals that paralysis disrupts.

Updated Feb 4

The FDA regulates drug approvals for cancer treatments in the United States. - 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.

Updated Feb 3

Federal agency responsible for protecting public health through regulation of medical devices, drugs, and other products. - 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 are using Neuralink implants to control computers, phones, and robotic arms with their thoughts. Several participants now exceed the cursor-control speed of able-bodied people using a mouse.

Updated Feb 2

Federal agency responsible for protecting public health through regulation of drugs, biologics, and medical devices. - Approved Yartemlea after extended review process

For decades, patients who developed transplant-associated thrombotic microangiopathy (TA-TMA) after stem cell transplants faced a grim reality: a life-threatening complication with no approved treatment. Mortality rates for high-risk cases reached 80-90%. In December 2025, the FDA approved Yartemlea, the first therapy for this condition, marking Seattle-based Omeros Corporation's first drug approval after 31 years. The company launched commercially on January 2, 2026, announced pricing at $36,000 per vial on January 7, and by late January both adult and pediatric patients were receiving treatment at transplant centers nationwide.

Updated Jan 31

The FDA released comprehensive guidance for therapeutic cancer vaccines in 2024 and has granted Breakthrough Therapy Designations to leading candidates. - 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 discovered these survivors still carry specialized immune cells capable of recognizing their cancer, pointing to a mechanism that could make therapeutic cancer vaccines work reliably.

Updated Jan 31

Federal agency responsible for drug approval and safety monitoring in the United States. - 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 discovered each psychiatric disorder has its own electrical fingerprint. The organoids diagnosed schizophrenia and bipolar disorder with 83% accuracy just by monitoring neural firing patterns—rising to 92% after gentle electrical stimulation. Machine learning algorithms spotted the differences invisible to human observers. The technology gained mainstream attention in January 2026 when NPR highlighted both the promise and ethical complexities of brain organoid research. By late January 2026, the American Psychiatric Association outlined plans to integrate biological biomarkers—including blood tests, neuroimaging, and digital monitoring—into the next DSM revision, signaling psychiatry's institutional shift toward biology-based diagnosis.

Updated Jan 31

Federal agency responsible for approving new drugs, including presbyopia treatments, for the U.S. market. - Approved YUVEZZI as fourth presbyopia eye drop

For 240 years, the solution to presbyopia—the gradual loss of near-vision that affects nearly everyone over 45—has been essentially the same: put lenses in front of your eyes. Benjamin Franklin invented bifocals in 1785. Today, two billion people worldwide rely on reading glasses. On January 29, 2026, the Food and Drug Administration approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution), the first dual-agent eye drop for treating this universal condition, marking a pivotal moment in pharmacological presbyopia treatment.

Updated Jan 30

Federal agency responsible for approving drugs and determining whether surrogate endpoints like proteinuria predict clinical benefit. - 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 of patients to kidney failure within a decade—the only options have been off-label immunosuppressants with mixed results. On January 13, 2026, that was supposed to change. Instead, the FDA extended its review of sparsentan by three months, requesting more data on clinical benefit. The announcement triggered a 33% intraday stock plunge and sparked multiple shareholder investigations into potential securities law violations. Two weeks later, CEO Eric Dube sold $1.56 million in company stock, a transaction drawing scrutiny given its timing.

Updated Jan 30

The agency whose regulatory decisions will determine when—and whether—the vaccine reaches patients. - Granted Breakthrough Therapy Designation

Cancer vaccines have promised to train the immune system against tumors for decades. None has delivered a durable, replicable benefit—until now. On January 20, 2026, Moderna and Merck reported that their personalized mRNA vaccine, combined with the immunotherapy Keytruda, cut the risk of melanoma recurrence or death by 49% at five years in a Phase 2b trial of 157 patients. The sustained result—identical to the three-year mark—suggests the vaccine permanently reprograms immune surveillance rather than offering temporary protection.

Updated Jan 25

Federal agency responsible for approving generic drugs and ensuring bioequivalence to brand-name versions. - Approved generic CF drugs after patent expiration

A generic version of Trikafta—the breakthrough 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 and has generated billions while remaining out of reach for patients in developing nations and many Americans with inadequate insurance.

Updated Jan 12

Federal agency regulating gene therapy approvals and safety oversight. - Approved six CAR-T therapies; removed REMS requirements in 2025

Gene therapy killed Jesse Gelsinger in 1999. His death triggered FDA shutdowns, lawsuits, and nearly ended the field. Fast forward to December 2025: British scientists published results showing that base-edited immune cells—a 'living drug'—achieved deep remissions in 82% of children with previously incurable T-cell leukemia. Three years after treatment, 64% remain disease-free. Some patients are off treatment entirely.

Updated Jan 9

Federal agency responsible for protecting public health by regulating drugs, biologics, and medical devices. - 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 that didn't exist when he was diagnosed. The treatment was designed, manufactured, approved, and delivered in 180 days.

Updated Jan 7