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New Drug Approvals

Source: Headline News

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC
FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection
FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer
FDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratitis
FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65
FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency
FDA Approves Duaklir Pressair (aclidinium bromide and formoterol fumarate) for Maintenance Treatment of Chronic Obstructive Pulmonary Disease
FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis
FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis
FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
FDA Approves Mayzent (siponimod) for Secondary Progressive Multiple Sclerosis
FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension
FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents
FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin