FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC.

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This ...

Georgia's congressional delegation is advocating for FDA reconsideration of the drug elamipretide for Hope Filchak.

MRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.

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

SAN FRANCISCO (KPIX) — With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved ...

VYNE Therapeutics updates on VYN202, addressing FDA clinical hold; progress made in psoriasis treatment development.

The program coordinates federal, state and local law enforcement agencies and has led to the dismantling of violent drug trafficking organizations, authorities said.