Needle mushrooms and other mushroom products are impacted by two separate recall notices from the Food and Drug ...

The FDA evaluates glofitamab and daratumumab for lymphoma and myeloma treatments, highlighting trial demographics and ...

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

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

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

While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

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

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

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

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

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 ...