Tag: Drug Approvals
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
FDA Approves Victoza Injection for Children 10 Years and Older
~64 percent of children treated with Victoza achieved HbA1c levels less than 7 percent
Chemoimmunotherapy Regimen Approved to Treat DLBCL
Polivy approved in combination with bendamustine, rituximab for diffuse large B-cell lymphoma
Emgality Receives First FDA Approval for Treating Cluster Headache
Patients treated with Emgality had 8.7 fewer cluster headache attacks at 3.0 weeks versus 5.2 with placebo
