Tag: Food & Drug Administration
FDA Approves First Noninjection Glucagon Therapy
Baqsimi nasal powder approved for emergency treatment of severe hypoglycemia in patients ≥4 years
Allergan Recalls Textured Breast Implants Linked to Lymphoma
FDA requested recall to protect women from breast implant-associated anaplastic large cell lymphoma
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
Medtronic Recalls Some Insulin Pumps Over Cybersecurity Concerns
The company and FDA say certain pumps are vulnerable to hacking
Dupixent Approved for Chronic Rhinosinusitis With Nasal Polyps
Clinical trials showed reduced nasal polyp size, congestion with Dupixent versus placebo
FDA Warns Two Kratom Marketers About False Claims
Warning letters sent to companies illegally selling unapproved, misbranded kratom-containing drug products
Vyleesi Approved for Hypoactive Sexual Desire Disorder in Women
FDA approved Vyleesi for premenopausal women; drug administered by subcutaneous injection
