FDA approves a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder drug Qelbree (viloxazine extended-release capsules) ...
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 ...
ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive updated data from the A...
FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transpl...
