FDA tentatively approves a Perrigo ANDA for a generic version of Valeant Pharmaceuticals acne drug Onexton Gel (clindamycin phosphate 1.2% and benzoyl...
The Washington DC District Court remands to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the companys Se...
FDA commissioner Scott Gottlieb orders the termination of an agency-sponsored animal (monkey) study of nicotine exposure over inhumane treatment conce...
FDA approves a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system.
FDA clears a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems for treating cancer patients.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for OPKO Healths Varubi (rolapitant) to be 3,070 da...
Federal Register notice: FDA announces that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee has been renewed for an additional...
Federal Register direct final rule: FDA amends its general biologics regulations relating to time of inspection requirements and to remove duties of i...