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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 Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
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 ...
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 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 ...
Opinion
On Sarepta, a Welcome FDA Reversal
After our editorial, the agency relents to allow a Duchenne treatment.
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 ...
FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers
Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.
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.
Business Wire8y
FDA Approves EMFLAZA™ (deflazacort) Tablets and Oral Suspension for ...
FDA Approves EMFLAZA™ (deflazacort) Tablets and Oral Suspension for the Treatment of Duchenne Muscular Dystrophy in Patients 5 Years and Older New Drug is First Widely-Applicable Treatment for ...