The U.S. Food and Drug Administration on Monday proposed a new guidance for devices used to monitor blood oxygen levels to ...

The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

Scott Gottlieb and Luciana Borio, a former director for medical and biodefense preparedness policy at the National Security ...

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...

Produce supplier Braga Fresh has issued a ‘precautionary advisory’ about the product, which is no longer in stores but might ...

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...

The impacted products have now been given a Class I risk classification by the U.S. Food and Drug Administration.

Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

With Donald Trump taking office and Robert F. Kennedy Jr. poised to assume the nation’s top health role, it seems the agency ...

On December 20, 2024, the FDA granted accelerated approval to the combination of encorafenib (Braftovi), cetuximab (Erbitux), ...

Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...