The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

Shares of healthcare tech company Privia Health Group (NASDAQ:PRVA) jumped 3.4% in the morning session as investors ...

Sarepta says it will continue to ship Elevidys despite FDA requests that it stop shipments of the Duchenne muscular dystrophy gene therapy, while Wall Street awaits earnings Monday from Verizon and ...

US stocks rose on Monday, with fresh records for the Nasdaq Composite (^IXIC) and S&P 500 (^GSPC) in sight as Wall Street ...

The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...