At the meeting, the Company and the FDA agreed that the proposed data package is sufficient to support the NDA submission.

The FDA avoided accountability at the Supreme Court for its reckless disregard for women’s health, but the fight is not over.

There’s no cure for Alzheimer’s disease, but in the past few years, researchers have found treatments that seem to stop some ...

The U.S. Food and Drug Administration has announced it is revoking the regulation authorizing the use of brominated vegetable ...

Adicet Bio (ACET) announced the FDA has granted Fast Track Designation to ADI-270 for the potential treatment of patients with ...

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...

Patients who received mammograms at a South Florida hospital in the past two years may have been given inaccurate results and ...

FDA's scientists found bacteria in a larger proportion of permanent makeup inks they tested than tattoo inks. Of the 49 ...

The recall of "Great Value Organic Black Chia Seeds 32 oz." was first announced on May 13, says the FDA's website. It was ...

AgileMD will begin testing its AI-powered device for predicting life-threatening deterioration of hospital patients.

In November last year, the FDA first proposed that it would ban BVO. The news came shortly after California banned BVO and ...

The U.S. Food and Drug Administration (FDA) is banning an additive typically used for sodas and other beverages after a ...