Sarepta says adverse event report for DMD gene therapy erroneously submitted

REUTERS: Sarepta Therapeutics Inc said on Thursday it was informed that an adverse event report was erroneously submitted to the U.S. health regulator regarding an ongoing study of the company's gene therapy for Duchenne muscular dystrophy .

The drug safety monitoring board has recommended the study to continue after a review, the company said in a statement. The illness was reported in the FDA adverse events database, which on its own cannot determine whether a drug is the cause of a problem, but can signal potential risks that warrant investigation.The FDA told Reuters that it was looking into the matter and said it does not have additional information on it.

Health Health Latest News, Health Health Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

Patient in Sarepta gene therapy trial develops serious illness; shares plungeREUTERS: Shares of Sarepta Therapeutics Inc plunged 12per cent after a notice from the U.S. health agency showed a patient in an ongoing study of ...
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »

Plant-based diet can help fight climate change: UN reportThe way the world manages land, produces and eats food has to change to curb global warming or food security, health and biodiversity will be at ...
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »