FDA accepts for review Leo Pharmas BLA for tralokinumab to treat adults with atopic dermatitis.
FDA accepts for priority review an AstraZeneca supplemental NDA for Brilinta (ticagrelor) for reducing subsequent strokes in patients who experienced ...
FDA clears a Baxter International 510(k) for the AltaporeShape Bioactive Bone Graft, which is intended to enhance bone growth and help achieve fusion.
Federal Register notice: FDA sends to OMB a new information collection entitled Health Care Providers Understanding of Opioid Analgesic Abuse Deterren...
Two Gibbons attorneys say the Delaware federal court has ruled that it has subject matter jurisdiction in a generic drug patent case even if the defen...
Federal Register notice: FDA seeks comments on a proposed information collection entitled Study of Disclosures to Health Care Providers Regarding Data...
FDA warns Washington Homeopathic Products about CGMP violations in its manufacturing of unapproved new drugs.
Biogen says it has filed a BLA with FDA for aducanumab to reduce the clinical decline of Alzheimers disease.