High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...

The FDA is expected to decide on treatments for bullous pemphigoid, hereditary angioedema, HIV PrEP, ovarian cancer, and RSV.

Recently approved medications for resistant hypertension, uncomplicated UTIs and menopausal hot flashes show potential as ...

Novo Nordisk’s oral Wegovy pill for chronic weight loss is under FDA review. If approved, it would be the first oral GLP-1 ...

The FDA has issued a Complete Response Letter to Telix Pharmaceuticals regarding the NDA for TLX101-CDx for the imaging of gliomas.

The FDA has approved a dihydroergotamine-based nasal powder for the acute treatment of migraine with or without aura in ...

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

The Food and Drug Administration (FDA) has tapped Vinay Prasad, a prominent critic of federal COVID-19 policies and a ...

WASHINGTON (AP) — Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, ...

The U.S. Food and Drug Administration has approved Edwards Lifesciences' SAPIEN 3 platform, a transcatheter aortic valve ...