FDA accepts for review an Orphalan NDA for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilsons Disease.
CDER Office of Generic Drugs reaches the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation...
FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTechs supplemental BLA seeking approval...
FDA approves Janssens Invega Hafyera six-month atypical antipsychotic injection for some adult schizophrenia patients.
Attorney Jordan Thomas asks FDA to halt clinical trials of Cassava Sciences simufilam until the agency thoroughly evaluates the scientific support for...
Federal Register notice: FDA announces an 11/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Levo Therapeutics NDA for Prader-Will...
FDA orders a drug class warning for Janus kinase inhibitors after reviewing a recent clinical trial that showed an increased risk of serious heart-rel...
FDA says it may approve returning ranitidine-containing products to the market based on new CDER research into the carcinogen NDMA.