Sarepta Elevidys FDA Investigation - Search News

News

FDA, Sarepta Therapeutics

The American Journal of Mana… · 30m

FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a voluntary pause.

Reuters on MSN · 5d

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 Sarepta Therapeutics' muscular disorder gene therapy Elevidys.

Fierce Pharma · 2d

FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.

Fierce Pharma2d

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 ...

FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Some results have been hidden because they may be inaccessible to you

Show inaccessible results