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

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

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

While MSN reports that Sarepta’s stock price began to rise on Monday on the heels of the announcement, 5 the company is still facing challenges. Shipments of the gene therapy for non-ambulatory ...

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

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

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

The FDA's top vaccine and gene therapy official resigned Tuesday after a public campaign against him led by right-wing influencer Laura Loomer.

Sarepta Therapeutics (Nasdaq: SRPT) has been cleared by the American medicines regulator to resume shipments of its gene ...

A deal with US WorldMeds includes the FDA-approved TCR therapy Tecelra and two clinical-stage cancer medicines.