Tag: Food & Drug Administration
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: Kratom Products Have High Levels of Heavy Metals
New concern added to list of the agency's warnings about the herbal supplement
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 to Update Medical Device Approvals Process
Revised process will ensure new medical devices meet safety and effectiveness standards
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 First-Line Tx for Peripheral T-Cell Lymphoma
Adcetris approved in combination with chemo to treat systemic anaplastic large cell lymphoma
