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 can begin shipping Elevidys therapy after FDA reverses pause, stock soars
Sarepta will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the US Food and Drug Administration ...
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 patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
BioSpace4d
Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
Sarepta shares soar 36% after FDA clears partial resumption of Elevidys shipments
Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...
Pharmaceutical Technology on MSN3d
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 ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...
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 ...
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...