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.
Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.
FDA warns Tesuque, NM-based Dr. Bernes Whole Health Products that it is marketing adulterated unapproved eye drops.
FDA opens an investigation into an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor ...
FDA issues a warning on Philips DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat.
