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.

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...

Trump's staff is laying the groundwork to prepare for a new FDA commissioner and make their mark at the agency.

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

With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval ...

The Food and Drug Administration (FDA) will begin collecting samples of raw cow’s milk cheese from across the U.S. to test for the presence of bird flu, spurred on by the ongoing outbreaks of ...

In other atopic dermatitis news, Galderma landed FDA approval for nemolizumab, brand name Nemluvio. The drug is an antibody designed to block IL-31, a signaling protein associated with the itch ...