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.
President Biden says his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to mitigate drug shortag...
