An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

Monitoring absolute neutrophil count levels beyond 2 years of clozapine treatment is no longer necessary, new international ...

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

A national recall with potential life-threatening consequences has caused further action by the U.S. Food and Drug ...

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

FDA is urging manufacturers of infant formula, baby food and children’s nutrition products to sharpen their recall ...

The US Food and Drug Administration (FDA) has announced the publication of more than 200 complete response letters (CRLs), ...

The study is scheduled to run through 2026, with Firefly commercially engaged to provide EEG systems, training, and full ...

Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.

The U.S. Food and Drug Administration announced a massive recall of 30 different kinds of produce over possible contamination ...

The decision marks the first of the company’s energy instruments to be cleared for the transection of lymphatic vessels.

Nicotine pouches, sometimes referred to as 'lip pillow' or 'upper decker,' are small microfiber pouches containing nicotine ...