The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...

Trump rescinded Executive Order 14087, "Lowering Prescription Drug Costs for Americans," which directed Medicare and Medicaid ...

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.

A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025. The BLA is based on data from the Clarity AD (Study ...

Financial writer analysis of Arcutis Biotherapeutics, Inc. stock surge and potential growth, FDA approvals, and partnerships ...

The FDA has accepted for review the New Drug Application for plozasiran for the treatment for familial chylomicronemia syndrome.

The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22 ...

The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.

Zai Lab Limited (ZLAB) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation or ODD to ZL-1310, a ...