Tag: Drug Approvals
FDA Approves First Generic Version of Epilepsy Drug Sabril
Generic equivalents held to same vigorous manufacturing standards as brand-name drugs
FDA Down to 5 Weeks of Funding to Review New Drug Applications
Agency cannot accept new fees or applications until the shutdown is over
FDA Approves Drugs for Treatment of Two Rare Blood Diseases
Elzonris approved to treat BPDCN; Ultomiris approved for paroxysmal nocturnal hemoglobinuria
FDA Approves Firdapse for Rare Autoimmune Disorder
First agency-sanctioned treatment for adults with Lambert-Eaton myasthenic syndrome
FDA Approves Treatment for AML Patients With Gene Mutation
Expanded approval also granted to mutation assay used to detect FLT3 mutation in AML patients
FDA Approves First Biosimilar to Non-Hodgkin’s Lymphoma Drug
Truxima approved to treat adults with CD20-positive, B-cell non-Hodgkin's lymphoma
FDA Approves Vitrakvi for Cancers With Certain Genetic Trait
Drug targets solid tumors with NTRK gene fusion without a known acquired resistance mutation
FDA Approves New Treatment for Acute Myeloid Leukemia
Randomized clinical trial showed significant improvement in overall survival with Daurismo
FDA Approves Drug for Treatment of Travelers’ Diarrhea
Aemcolo not indicated for patients with diarrhea complicated by fever and/or bloody stool
FDA Approves Drug to Treat Rare Immune Disease
Gamifant first drug to be approved specifically for primary hemophagocytic lymphohistiocytosis
