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 ...

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 ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...

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.

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.

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 recommend a formula for COVID-19 vaccines for the 2025-2026 season.

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.