Tag: Food & Drug Administration
FDA Approves Poteligeo for Rare Types of Non-Hodgkin Lymphoma
Drug approved to treat relapsed or refractory mycosis fungoides and Sézary syndrome
FDA Approves Azedra for Rare Adrenal Tumors
First systemic treatment for patients who experience tumor-related symptoms such as hypertension
FDA Approves Magnetic System for Guiding Lymph Node Biopsies
Sentimag System uses magnetic detection to identify sentinel lymph nodes for surgical removal
FDA Grants First Approval for CA Drug Under New Pilot Programs
Ribociclib approved in combo with AI as endocrine tx for HR-positive, HER2-negative advanced breast CA
FDA Warns Against Risks of Contaminated Synthetic Cannabis
Risk of bleeding associated with contamination of synthetic marijuana products with brodifacoum
FDA Approves Tibsovo for Acute Myeloid Leukemia
Approved for adults with relapsed or refractory acute myeloid leukemia who have IDH1 mutation
FDA Proposes New Rule on Food Labeling in Vending Machines
Revised rule suggests that type size on packaged food must be 1.5 times size of net weight declaration
Bayer Stops U.S. Sale of Essure Birth Control Implant
Problems with device include chronic pain and perforations of the uterus and fallopian tubes
FDA Recalls Drugs Containing Active Ingredient Valsartan
All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
