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Sarepta shares more Elevidys safety data in response to patient group's FDA petition

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

How the Moms and Dads of Patients Won Sarepta’s Drug a Reprieve

The deaths prompted the FDA to ask Sarepta to stop shipping Elevidys for all patients, but the company refused to do so. Days later, it changed tack in order to maintain what it said was a “positive ...

Stealth resubmits rare disease drug to FDA

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

Dyne Therapeutics Receives FDA Breakthrough Therapy Designation for Duchenne Muscular Dystrophy Therapy

Dyne Therapeutics Inc. (NASDAQ:DYN) is one of the best small cap stocks with biggest upside potential. On August 4, Dyne Therapeutics announced that its investigational therapy, called DYNE-251, ...
The American Journal of Managed Care6h

FDA Approves Semaglutide for MASH With Fibrosis

The FDA has granted accelerated approval to semaglutide (Wegovy; Novo Nordisk) injection 2.4 mg for the treatment of adults with metabolic dysfunction–associated steatohepatitis (MASH) with moderate ...