Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

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

After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.

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 ...

Analysts’ view on the stock has dramatically changed over the past few months. Currently, only 21% of the 29 analysts ...

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

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

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

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 ...