"The claim that the FDA is suspending routine food safety inspections is false. FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ...

Gerard Criner, MD, FACP, FACCP, MATINEE investigator ... chronic obstructive pulmonary disease (COPD). Earlier today, the FDA approved mepolizumab (Nucala; GSK) as an add-on maintenance treatment ...

LOOKING INTO VAX CRYSTAL BALL — The Covid-19 vaccine framework that FDA Commissioner Marty Makary teased last week is expected to drop today, two people familiar with the plan and granted ...

The vaccine's prospects were thrown into doubt after the FDA missed its April 1 target to approve the shot, which is a more traditional protein-based vaccine unlike its messenger RNA-based rivals.

Biohaven is giving investors whiplash. Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed an approval decision on its rare disease candidate ...

The agency moved this week to ban the products, which are used to prevent cavities. By Dani Blum The Food and Drug Administration will work to pull fluoride supplements for children from the ...

The head of the U.S. Food and Drug Administration (FDA) is sounding the alarm on a dangerous drug referred to as "gas station heroin," that can lead to serious harm, including death. FDA ...

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 ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA ...

The FDA has appointed its first chief artificial intelligence officer, with an eye on supporting the agency’s internal IT systems and potentially accelerating its reviews of medical products.

The FDA has issued an important alert regarding topical finasteride, highlighting significant health risks that many users remain unaware of until experiencing adverse effects. This warning comes ...