The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.

Jeff Yass, co-founder of ByteDance investor Susquehanna International Group, made his largest ever political donations to Trump’s MAGA Inc. super PAC in the first half of the year, per a new FEC ...

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

Prasad, a longtime critic of the FDA’s leniency in drug approvals, joined the agency in May. WASHINGTON — The Food and Drug ...

Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.

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

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

Key Takeaways Dr. Vinay Prasad is stepping down as top vaccine official at the U.S. Food and Drug AdministrationHis short time in the role drew criticism from multiple frontsHe paused shipments of a ...

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

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

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