Shares of Mustang Bio ( NASDAQ: MBIO) jumped on Monday after the company said that the U.S. FDA has granted orphan drug ...

The safety update for Vyvgart rattled argenx’s shares on Monday, a reaction that analysts at William Blair said was “overdone ...

Two senior officials at the FDA's drug promotion regulatory office have resigned, leading to speculation that a clampdown on some direct-to-consumer (DTC) advertising of medicines could be on the way.

The FDA is moving at breakneck speed to roll out a generative artificial intelligence (AI) tool for speeding up regulatory reviews, announcing its launch nearly a month ahead of the 30th June ...

The Prescription Drug User Fee Act typically calls for a period of 10 months for the FDA to review such applications, although drugs that are deemed a priority have a review period of six months.