Tag: Drug Approvals
Evolution of Approval, Regulation Processes for Drugs Explored
FDA drug review times down from 1983 to 2017, but time from clinical testing to approval did not change
New Alzheimer Disease Drug to Be Submitted for FDA Approval
New analysis of study results suggests highest dose of aducanumab may help slow cognitive decline
FDA Approves First Noninjection Glucagon Therapy
Baqsimi nasal powder approved for emergency treatment of severe hypoglycemia in patients ≥4 years
FDA Grants First Approvals for Generic Versions of Lyrica
Generic versions approved for neuropathic pain management, fibromyalgia, partial onset seizures
Recarbrio OK’d for Complicated Urinary Tract, Intra-Abdominal Infections
Drug approved to treat patients with limited or no alternative antibacterial drugs to treat infection
Xpovio With Dexamethasone Approved for Refractory Multiple Myeloma
Drug combination approved to treat patients who have failed at least five other treatments
Soliris Approved to Treat Neuromyelitis Optica Spectrum Disorder
In clinical trials, Soliris reduced NMOSD relapses by 94 percent compared with placebo
Dupixent Approved for Chronic Rhinosinusitis With Nasal Polyps
Clinical trials showed reduced nasal polyp size, congestion with Dupixent versus placebo
Vyleesi Approved for Hypoactive Sexual Desire Disorder in Women
FDA approved Vyleesi for premenopausal women; drug administered by subcutaneous injection
FDA Expands Cystic Fibrosis Treatment Approval to Children Ages 6 to 12
Symdeko previously approved for patients ≥12 years with cystic fibrosis and certain genetic mutations
