Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

But it’s unclear if the evidence provided to support continued use of fluoridated supplements will matter. The FDA said in ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater than currently accepted.

The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of the monoclonal antibody drug class that has led to several deaths.

A Food and Drug Administration panel discussing the use of antidepressants during pregnancy Monday largely amounted to ...

FDA raised safety concerns for Vyvgart Hytrulo in CIDP, while Argenx moves ARGX-119 into late-stage trials for rare neuromuscular disease.