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Just The News4h

FDA allows distribution of muscular dystrophy drug again after public criticism

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

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 ...

US FDA's chief medical and science officer Prasad departs agency

Vinay Prasad, the U.S. Food and Drug Administration's chief medical and science officer, has left the health regulator, the U ...
Fierce Pharma1d

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 ...

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
The New York Sun2h

FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to $3.2 Million Per Dose Therapy for Rare Disorder in Boys

Dr. Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on ...
Opinion

On Sarepta, a Welcome FDA Reversal

After our editorial, the agency relents to allow a Duchenne treatment.

FDA opens probe into mysterious death linked to gene therapy

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
CBS News8y

First drug for Duchenne muscular dystrophy, Exondys 51, gets FDA ...

The FDA cleared Sarepta Therapeutics’ Exondys 51 for a rare form of Duchenne muscular dystrophy, a deadly inherited disease that affects boys.