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

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...

The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...

Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the ...

This week on "The Readout LOUD," STAT's biotech reporters parse what Vinay Prasad's ouster means for biotech and the FDA.

Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.

Tidmarsh will temporarily guide CBER’s regulatory activities while the FDA searches for a permanent department lead.

PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...

The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of ...