The U.S. Food and Drug Administration on Monday proposed a new guidance for devices used to monitor blood oxygen levels to ...
Scott Gottlieb and Luciana Borio, a former director for medical and biodefense preparedness policy at the National Security ...
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.
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 ...
A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.
The Food and Drug Administration (FDA) will begin collecting samples of raw cow’s milk cheese from across the U.S. to test ...
Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic ...
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's ...
Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...