Sources also say that the administration plans to split CBER in two, with one of the section focused entirely on vaccines.

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

After our editorial, the agency relents to allow a Duchenne treatment.

Shares of Sarepta Therapeutics Inc. (SRPT) traded 20% higher on Tuesday afternoon after the U.S. Food and Drug Administration ...

Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...