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

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

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

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 ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

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 latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...

The review notes that the current legal limit for drinking water in the bloc is 1.5 milligrams of fluoride per liter, which ...

For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...

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.

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