CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Sarepta investors who were adversely affected by alleged ...

Sources also say that the administration plans to split CBER in two, with one of the section focused entirely on vaccines.

In a striking bipartisan move, the Senate Appropriations Committee voted 26-3 to boost the NIH’s budget by $400 million — rejecting the Trump administration’s proposed $17 billion cut and sweeping ...

Dr George Tidmarsh, a former pharmaceutical executive who joined the FDA this month, will take over Prasad’s role temporarily.

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 ...

Allogene Therapeutics has reported a patient death tied to its anti-CD52 monoclonal antibody used for lymphodepletion in its ...

OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

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

Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) is a biotechnology company specializing in RNA interference (RNAi) therapeutics ...

The former official, Vinay Prasad, had been on the job three months and had recently come under attack by conservative ...