A federal court sentences pharmaceutical marketer Quintan Cockerell to two years and five months in prison and orders him to pay over $59 million in r...
CDRH announces new organizational changes to help it meet commitments under the Medical Device User Fee Amendments reauthorization and other strategic...
Baxter recalls its Life200 Ventilator System due to the potential for battery failure involving its charging dongle.
FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.
Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical artificial intelligen...
Citing payor management concerns, Indivior says it is discontinuing sales and marketing for schizophrenia drug Perseris (risperidone).
Bausch+Lombs Synergetics unit recalls its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal (back of the eye) i...
Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmatory study failed to de...
