Tag: Drug Approvals
FDA Approves Imbruvica to Treat Chronic Graft Versus Host Disease
Drug sanctioned for patients with cGVHD who do not respond to other forms of therapy
FDA Approves First Neonatal MRI Device
Device designed for neonatal brain and head imaging in intensive care units
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
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
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
