FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs Eliquis with a higher ...
FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.
FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.
FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (difelikefalin acetat...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (trilaciclib), indicate...
Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.
FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure drugs.
