FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...

Dr. Vinay Prasad is stepping down as the Food and Drug Administration's top vaccine regulator after a brief tenure.

The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...

A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman's personalized ...

The 15-minute digital lateral flow immunoassay originally obtained Emergency Use Authorization from the US FDA in 2020.

Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action ...

Apellis Pharma (APLS) stock in focus as the FDA expands the label for its injectable therapy Empaveli to treat rare kidney ...

Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading ...

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

MAGiC Sweep is claimed to be the first robotically navigated electrophysiology mapping catheter approved by the FDA.

For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...