Exelixis, Inc.

Stories

FDA delays decision on Exelixis' colorectal cancer drug zanzalintinib

Seeking FDA approval for zanzalintinib in metastatic colorectal cancer

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 1 hour ago

FDA grants final approval to Handa's alternate-salt cancer drug OMCAZIO

Money Moves

Originator of Cabometyx; fought OMCAZIO approval

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.

Updated 2 hours ago