A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

For both foods and drugs, most foreign inspections were pre-announced; the agency also re-emphasized its ban on inspectors ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency’s top regulator of vaccines, gene ...

Recent FDA alert reveals concerning side effects of topical finasteride hair treatments that may persist long after stopping ...

President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines ...

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...