(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 ...

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

The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...

A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...

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

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

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

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

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

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

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...