News

Fierce Pharma4d
FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
Sarepta denies Elevidys is linked to latest patient death in Brazil
Sarepta Therapeutics (SRPT) in focus as the biotech says the death of a patient who had received its gene therapy Elevidys ...
Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars
Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...
Pharmaceutical Technology on MSN4d
Sarepta allowed to continue US Elevidys shipments
It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome ...
GEN - Genetic Engineering and Biotechnology News5d
FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys
The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its ...
Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...
Sarepta shares soar 36% after FDA clears partial resumption of Elevidys shipments
Sarepta Therapeutics shares jumped over 36% in premarket trading on Tuesday after the company said it had received US Food ...
Chemistry World2d
Sarepta gene therapy deaths highlight tragic rare disease dilemma
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...