Tag: Food & Drug Administration
FDA Approves Drugs for Treatment of Two Rare Blood Diseases
Elzonris approved to treat BPDCN; Ultomiris approved for paroxysmal nocturnal hemoglobinuria
FDA Announces Safety Monitoring Measures for the Essure Device
Measures include having women in the postmarket surveillance study followed for five years, not three
FDA Warns Companies on Unsafe, Unapproved Stem Cell Treatments
Patients contracting deadly infections at clinics offering the unapproved treatments
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
