The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The U.S. Food and Drug Administration approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product, which is indicated to control high blood sugar in adults with Type 2 diabetes as well as adults and pediatric patients with Type 1 diabetes.
After an earlier rejection from the U.S. Food and Drug Administration, Merck’s vaunted checkpoint inhibitor Keytruda won approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer.
The U.S. Food and Drug Administration approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections in pediatric patients as young as newborns.
Albireo Pharma, a spinout of AstraZeneca, won regulatory approval for the first drug aimed at pruritus in patients with all subtypes of progressive familial intrahepatic cholestasis (PFIC).
The U.S. Food and Drug Administration granted approval to Octapharma USA for Octagam 10% [Immune Globulin Intravenous (Human)], the first intravenous immunoglobulin to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease.
The U.S. Food and Drug Administration approved Rezurock (belumosudil) as a new treatment option for anyone over 12 years of age with chronic graft-versus-host disease after two prior lines of therapy have failed.
The U.S. Food and Drug Administration approved Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
Abbott’s Xience family of stents received U.S. Food and Drug Administration approval for one-month (as short as 28 days) dual anti-platelet therapy labeling for high bleeding risk patients in the United States.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Biogen’s Alzheimer’s disease medicine Aduhelm (aducanumab), which has a list price of $56,000 per year.
