Provepharm recalls one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL due to a customer complaint about visible black particulate matter ...
FDA approves an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as maintenance dosing in Alzh...
Pfizer agrees to pay $59.7 million to resolve allegations that its subsidiary, Biohaven Pharmaceutical, engaged in previous illegal kickback schemes.
Vanda Pharmaceuticals files an NDA for tradipitant for treating motion sickness.
FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Navigation Software Version 3.0, which the company says introduces an intraoperative computed ...
FDA clears an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters.
FDA approves a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder drug Qelbree (viloxazine extended-release capsules) ...
FDA grants Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging prostate cancer lesions in p...
