A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the leaders in gene therapy goes through a “strategic ...

U.S. President Donald Trump reportedly ordered the removal of Vinay Prasad as director of the FDA’s Center for Biologics ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...

Vinay Prasad, appointed as FDA's top vaccine official, faced criticism and backlash during his short tenure. Controversies surrounded gene therapy safety and regulatory decisions affecting futures of ...

Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver ...

Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...