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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 ...
BioSpace11h

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Goldman Sachs' Salveen Richter on Sarepta's ongoing troubles, opportunities in biotech

Salveen Richter, Goldman Sachs lead biotech analyst, joins 'Squawk Box' to discuss the troubles facing Sarepta and its ...
BioWorld4h

CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla

After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene ...
BioSpace9h

Sarepta Fallout Continues with EU’s Negative Opinion of Elevidys in Ambulatory Patients

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

Sarepta's licensing partner Arrowhead expects near-term payments despite setbacks

Sarepta Therapeutics' licensing partner Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone ...
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