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GlobalData on MSNCHMP rejects Elevidys in latest setback for SareptaSarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be ...
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment continues.
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing ...
Sarepta’s Elevidys will remain on the market with a black box warning. But this gene therapy for Duchenne muscular dystrophy still faces commercial headwinds and analysts say the company has ...
The Food and Drug Administration rejected a marketing application from Capricor Therapeutics for a cell therapy to treat Duchenne muscular dystrophy, the company said Friday.  In its letter ...
Capricor slumps 33% as the FDA rejects its BLA for DMD drug, deramiocel, citing lack of effectiveness data and CMC issues.
Sarepta has also announced an FDA-requested black box warning be included on Elevidys’ label for acute liver injury and failure.
Treasury Secretary Scott Bessent dismissed the idea that the dollar’s recent declines raise concerns about its status as the world’s key currency.
A federal judge on Monday rejected Apple’s request to dismiss the Department of Justice’s (DOJ) antitrust case against the iPhone maker in an early win for the agency. U.S. District Judge ...
State rejects Tommy Zeigler's request for a hearing based on new DNA evidence CBS Cancels 'Late Show,' Ending Stephen Colbert's Run After Decades On Air Warren Buffett has set alarm bells ringing ...
A San Antonio local is hoping The All-American Rejects choose her house for their ongoing "House Party Tour." Here's everything we know about the submission.
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