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The U.S. approval and regulation processes for pharmaceutical agents have evolved during the last four decades

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
A new drug to treat early Alzheimer disease will be submitted to the U.S. Food and Drug Administration for approval

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
The U.S. Food and Drug Administration has approved the first noninjection glucagon therapy for emergency treatment of severe hypoglycemia

FDA Approves First Noninjection Glucagon Therapy

Baqsimi nasal powder approved for emergency treatment of severe hypoglycemia in patients ≥4 years
Nine drug companies have received approval for the first generic versions of Lyrica (pregabalin)

FDA Grants First Approvals for Generic Versions of Lyrica

Generic versions approved for neuropathic pain management, fibromyalgia, partial onset seizures
The antibacterial drug product Recarbrio (imipenem

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 (selinexor) tablets have been approved for use in combination with dexamethasone to treat adults with relapsed refractory multiple myeloma

Xpovio With Dexamethasone Approved for Refractory Multiple Myeloma

Drug combination approved to treat patients who have failed at least five other treatments
The U.S. Food and Drug Administration has approved Soliris (eculizumab) injection as the first treatment for neuromyelitis optica spectrum disorder

Soliris Approved to Treat Neuromyelitis Optica Spectrum Disorder

In clinical trials, Soliris reduced NMOSD relapses by 94 percent compared with placebo
Dupixent (dupilumab) has been approved for the treatment of nasal polyps in adults with chronic rhinosinusitis

Dupixent Approved for Chronic Rhinosinusitis With Nasal Polyps

Clinical trials showed reduced nasal polyp size, congestion with Dupixent versus placebo
Vyleesi (bremelanotide) has been approved to treat acquired

Vyleesi Approved for Hypoactive Sexual Desire Disorder in Women

FDA approved Vyleesi for premenopausal women; drug administered by subcutaneous injection
The indication for a cystic fibrosis treatment

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