The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment continues.

The reversal is part of a larger effort at the FDA to limit vaccinations to people 65 and older.

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing ...

Capricor, which was seeking approval of Deramiocel for the treatment of cardiomyopathy associated with DMD, said the FDA issued a so-called complete response letter, indicating the agency won't ...

The FDA has rejected Unicycive's kidney disease drug due to manufacturing issues. The company is seeking a new manufacturer and plans a meeting with the FDA to resolve the agency’s concerns.

A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity. That’s what scientists at a leading research institute have found.

Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response ...

Read about Sarepta Therapeutics Inc (1SRPT:XMIL) stock and today's latest news and financial updates.

With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved treatments in the rare disease ...

Today's biotech news covers limited approval for Moderna's Covid shot for kids, FDA rejecting Capricor's Duchenne therapy, and more.