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

In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy ...

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in ...

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

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

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 ...

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

The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

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

Johnson & Johnson MedTech (NYSE: JNJ) today announced FDA approval for an update to its Varipulse platform's irrigation flow ...