FDA Alerts
Device to Reduce Chemo Hair Loss Cleared for Marketing
Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
FDA Approves New von Willebrand Rx
The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD).
Rare Enzyme Disorder Rx Approved
Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
Type 2 Diabetes Rx May Pose Serious Health Risks
An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections.
Weight Loss Supplement May Contain Hidden Drug
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Lipo Escultura, a product promoted and sold for weight loss on www.lipoesculturatreatment.com by JAT Productos Naturales Corp., but may also be distributed under the following aliases: Lipo Escultura Corporation and JAT Natural Products Corp.
FDA Approves New Multiple Myeloma Rx
Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.
Multivitamins High in Vitamin D Recalled
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida.
First Flu Vaccine with Adjuvant Approved
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant.
FDA OKs Lung Cancer Rx Portrazza
The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
Anthrax Vaccine Gets FDA Nod
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.