The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling ...
SANTA BARBARA, Calif. - The community can now test for COVID-19 and the flu at the same time from their home. The Food and Drug Administration (FDA) just ...
The reconsideration follows an Oct. 11 lawsuit that prompted U.S. District Judge Mark Pittman to temporarily halt legal proceedings to give the FDA time to reassess its ruling.
The recall was originally announced Sept. 6 by the Centers for Disease Control and Prevention. It was upgraded Sept. 30 to ...
CMR Surgical obtained a de novo clearance from the FDA for its Versius surgical system, finally allowing its modular, ...
Heidelberg Engineering, a global leader in ophthalmic imaging and healthcare data solutions, announces FDA clearance of the SPECTRALIS® Flex Module. This innovative, multimodal, diagnostic ...
Hims & Hers Health (HIMS) is enjoying a morning surge after the Food and Drug Administration (FDA) dropped fresh news ...
BL-M11D1, a CD33-binding antibody-drug conjugate, is being evaluated for the treatment of patients with acute myeloid ...
Imuldose will be marketed in the United States by Accord BioPharma and is expected to launch in the first half of 2025.
The new drug would allow patients to produce the needed clotting protein for an extended period, reducing the need for ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...