News

pharmaphorum2m
Vinay Prasad abruptly departs from the FDA
Vinay Prasad has stepped down as head of the FDA's Center for Biologics Evaluation and Research (CBER), less than three ...
Just The News5h
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 ...
The New York Sun3h
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 ...
News Nation on MSN1d
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
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 ...
STAT18h
Pharmalittle: We’re reading about a new Novo Nordisk CEO, an FDA reversal on Sarepta, and more
Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...
BioSpace4d
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 Pharma6d
Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...