The risk level is the FDA's second most severe level as it could cause "temporary or medically reversible adverse health consequences." The bottles contain the "presence" of nitrosamine drug ...

I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots," FDA Commissioner Dr. Marty Makary told CBS News chief Washington correspondent ...

The FDA issued a public alert on Tuesday concerning generic versions of a widely-used hair loss drug that is frequently distributed by popular telehealth brands like Hims and Keeps. The agency ...

This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use," FDA Commissioner Martin A.

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...

The decision is a win for Lilly — which had been pressing the FDA to take the step for months — and is expected to impact how patients access the drugs, including how much they pay.

DSM-Firmenich says the FDA is expected to decide within the next 17.5 months — by March 2026 — on the company's request to approve the sunscreen ingredient bemotrizinol, branded as PARSOL Shield.

Under that program, the FDA sends milk samples — some of which are intentionally tainted — to labs at dairy processing centers to test whether the labs correctly screen them. An FDA ...

The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.

For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage ...

The FDA made the announcement in statement about "an aggressive timeline to scale use of artificial intelligence internally across all FDA centers by June 30, 2025, following the completion of a ...