The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues ...

On May 20, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine.. The agency said it would approve new versions of the vaccine only for adults 65 ...

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

The Food and Drug Administration has outlined new regulations for COVID-19 booster shots, setting stricter approval standards for younger and healthier Americans. CBS News medical contributor Dr ...

A progressive approach to drug approval would balance the reality of drug safety and efficacy research with the desire to get innovative products to patients faster.

COVID-19 vaccine changes What we know: The Trump administration will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.

Mr. Hogberg said it takes about eight to 12 years for a new drug to receive approval from the Food and Drug Administration. He believes transforming the FDA’s regulatory process could help ...

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should be targeted by updated versions of the vaccines.

Advisers to the Food and Drug Administration met Thursday to recommend a formula for COVID-19 vaccines for the 2025-2026 season.