Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...

The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

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

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

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

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

At a recent FDA panel on SSRIs in pregnancy, the chair suggested rising antidepressant use may be contributing to — not ...

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.