Tag: Food & Drug Administration
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
Postmarket Safety Events for 32 Percent of Novel Therapeutics
Thirty-two percent of 222 FDA approved novel therapeutics from 2001 to 2010 were affected
FDA Approves Radicava for Amyotrophic Lateral Sclerosis
Radicava, given intravenously, slows physical decline in patients with ALS
Enzyme Replacement Drug OK’d for Form of Batten Disease
Brineura will be used to treat children with late infantile neuronal ceroid lipofuscinosis type 2 Batten
FDA Approves Kinase Inhibitor for Treatment of AML
Midostaurin, in combination with chemotherapy, treats acute myeloid leukemia in adults
Regorafenib Approved for Hepatocellular Carcinoma
It is the first approved treatment for HCC in almost a decade
FDA Warns Companies Selling Fraudulent Cancer Treatments
The unapproved products are often advertised as 'natural' and labeled as supplements
FDA OKs Vagus Nerve Stimulator to Treat Cluster Headaches
Hand-held, noninvasive device provides new option
FDA Approves First Drug for Treatment of Tardive Dyskinesia
Ingrezza (valbenazine) capsules approved for treatment of adults with tardive dyskinesia
