Sarepta Therapeutics (SRPT) says adverse event report was erroneously submitted to FDA's FAERs
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Sarepta Therapeutics Comments on Erroneous Submission to US FDA Adverse Event Reporting System (FAERS)
August 8, 2019 3:27 PM EDTCAMBRIDGE, Mass., Aug. 08, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, was informed earlier today that an adverse event report was erroneously submitted to the FDAs adverse event reporting system (FAERs), a post-marketing surveillance database for approved therapies. Our investigation to date indicates that this report was not submitted to the FAERs database by a Sarepta employee or the studys principal investigator. Â
The submission reported a case of rhabdomyolysis in a participant in Sareptas Study SRP-9001-102, a... More
