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 ...

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

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 ...

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

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 ...

Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...

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

George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...