Agriculture Secretary Brooke Rollins and Health and Human Services Secretary Robert F. Kennedy Jr. will hold a news briefing ...

On July 1, the FDA upgraded its recall of Alma Pak organic blueberries to Class I—the highest alert—after Listeria ...

(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

The U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition ...

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...

Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.

Finerenone gained FDA approval for heart failure treatment, showcasing significant benefits in reducing cardiovascular events ...

The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, ...

Approval of Kerendia was based on results from the Phase III FINEARTS-HF trial, which demonstrated statistically significant ...

Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...

The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH), hosted a workshop ...