Federal Register notice: FDA seeks comments on an information collection extension related to Providing Waiver-Related Materials in Accordance With th...
Federal Register notice: FDA announces a 6/20 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a supplemental NDA for Novo Nor...
Federal Register notice: FDA seeks comments on an information collection extension on Prescription Drug Advertisements; OMB Control Number 09100686....
Respironics begins a Class 1 recall of its V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor...
FDA clears a Soterix Medical 510(k) for its IontoDC device, which uses a direct current to introduce ions of soluble salts or other drugs into the bod...
Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple...
FDA releases a Form 483 after a January inspection cited significant GMP issues at Sancilio & Co.s Riviera Beach, FL manufacturing facility.
A 5/24 FDA Oncologic Drugs Advisory Committee plans to discuss agency concerns over uncertainty in the magnitude of treatment effect due to unplanned ...