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Roche Holding AG temporarily halted shipments of its muscular disorder gene therapy, Elevidys, outside the U.S., mirroring its U.S. partner Sarepta Therapeutics. The pause affects orders relying on ...
Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., ...
AstraZeneca plans a $50 billion investment to expand its US manufacturing and research capacity by 2030, driven by tariff ...
Opendoor Technologies shares are up nearly 12% as traders continue to buy the meme stock after [Monday's extreme volatility]( ...
WASHINGTON — OpenAI CEO Sam Altman warns of a looming fraud crisis in the financial industry due to AI's ability to mimic voices. Speaking at a Federal Reserve conference on ...
Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular ...
Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
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