Tag: Food & Drug Administration
FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return
Drug is a kinase inhibitor that works by blocking several enzymes that promote cell growth
Potential First U.S. Gene Therapy Now Under FDA Review
Tisagenlecleucel could be a one-time treatment for children and young adults with advanced leukemia
FDA Approves Endari for the Treatment of Sickle Cell Disease
First treatment approved for patients with sickle cell disease in almost 20 years
FDA Expands Use of Cooling Cap to Cut Chemo-Related Hair Loss
Treatment now approved for patients receiving chemotherapy for solid tumors
Many Adverse Events Related to Cosmetics Go Unreported
Cosmetics and personal care products get little regulatory scrutiny
FDA Requests Removal of Opana ER From Market
Agency says the medication's risk for abuse now outweighs any benefit
FDA Approves Keytruda for All Cancers With Genetic Biomarker
First medication sanctioned for any cancer, regardless of origin
FDA Approves Actemra to Treat Giant Cell Arteritis
New indication provides the first FDA-approved therapy specific to this type of vasculitis
FDA OKs Kalydeco for Additional Mutations in Cystic Fibrosis
Decision based on results of laboratory testing and previous clinical trials
FDA Approves New Device to Treat Esophageal Atresia
Device uses magnetic catheters to draw the upper and lower esophagus together
