Tag: Drug Approvals
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
FDA Approves New Version of OTC Primatene Mist
Primatene Mist approved to provide temporary relief for symptoms of mild, intermittent asthma
FDA Approves Powerful New Opioid Despite Criticisms
Dsuvia use restricted to operating rooms or on the battlefield
FDA Approves First New Influenza Drug in 20 Years
Antiviral drug reduces symptoms of uncomplicated influenza when taken within 48 hours of onset
