Tag: Food & Drug Administration
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
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