News

STAT11h
For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak
As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...
BioSpace2h
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 ...
CHMP rejects Elevidys in latest setback for Sarepta
Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...
Investor's Business Daily on MSN2h
Sarepta Therapeutics' Brutal Week Continues With Bad News Out Of Europe
Sarepta Therapeutics' brutal week continued Friday after European officials rejected the company's controversial gene therapy ...
BioSpace4h
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 ...
Fierce Pharma21h
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...