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 ...

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.

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 ...

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 Supreme Court ruled unanimously Wednesday that the Food and Drug Administration properly rejected applications to market fruit- and dessert-flavored liquids for electronic cigarettes that the ...

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.

According to an alert from the U.S. Food and Drug Administration (FDA), the product could contain “glass fragments.” The department alerted that certain bread products from Upper Crust Bakery ...

The FDA has suspended its food testing lab quality control program due to staffing cuts. Staffing cuts at HHS agencies, including the FDA, have occurred since Robert F. Kennedy Jr.'s confirmation ...

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 ...