The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...

Duchenne muscular dystrophy is characterized by a mutation in the DMD gene that leads to a lack of dystrophin and muscle loss ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...

The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the ...

Elevidys has been given full approval to treat ambulatory patients with DMD, with an accelerated approval in non-ambulatory ...

Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the best mid cap growth stocks to invest in now. Earlier on June 4, Sarepta ...

Shares in both companies were down following news of the second death, casting fresh safety concerns over Elevidys.

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

The FDA is investigating two deaths in non-ambulatory Duchenne muscular dystrophy patients who received a Sarepta gene ...

Editas Medicine (NASDAQ: EDIT) and Sarepta Therapeutics (NASDAQ: SRPT), two biotech companies, have encountered severe ...

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...