Tag: Food & Drug Administration
FDA: Generic Copaxone Approved for Multiple Sclerosis
FDA reviewed additional information to ensure generic is as safe and effective as brand-name drug
FDA Approves New Test That Helps Diagnose Gastroparesis
Test is less invasive and can be administered in the physician's office
FDA Approves New Miniature Blood Pump System
Maintains circulation during high-risk percutaneous coronary intervention procedures
FDA Expands Approval for ‘Valve in Valve’ Aortic Replacement
Now includes people at risk for open-heart surgery complications
FDA Approves New Treatment for Anthrax
FDA cites preparedness for intentional release of anthrax
FDA: Eylea Approval Expanded to Include Diabetic Retinopathy
Among people with diabetic macular edema
FDA Approves Cholbam for Rare Bile Acid Synthesis Disorders
Drug is approved as an oral treatment for children aged 3 weeks and older, and adults
FDA Updates Recs for Cleaning of Reusable Med Devices
Updated rules in response to contaminated duodenoscopes
FDA Approves Unituxin for High-Risk Neuroblastoma
First approval for a therapy aimed specifically to treat the rare pediatric cancer
FDA Approves Cresemba for Serious Fungal Infections
New drug targets cell walls of the fungi; available in oral and intravenous formulations
