FDA Approves Seglentis (celecoxib and tramadol hydrochloride) for the Management of Acute Pain
October 18, 2021 -- The U.S. Food and Drug Administration (FDA) approved Seglentis (celecoxib and tramadol hydrochloride), a proprietary product developed by Esteve Pharmaceuticals' R&D team.
FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease
PRINCETON, N.J., Oct. 18, 2021 /PRNewswire/ -- Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced that the U.S. Food and Drug Administration (FDA) has approved Tyrvaya (varenicline solution) Na
FDA Approves Rethymic (allogeneic processed thymus tissue-agdc) One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia
Rethymic is the first and only FDA-approved treatment indicated for immune reconstitution in pediatric patients with congenital athymia Children with congenital athymia are born without a thymus causi
FDA Approves Tavneos (avacopan) for the Adjunctive Treatment of ANCA-Associated Vasculitis
First FDA-approved orally-administered inhibitor of the complement 5a receptor SAN CARLOS, Calif., Oct. 08, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S. F
FDA Approves Livmarli (maralixibat) for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 29, 2021 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leader in rare liver disease, today announced that the U.S. Food and Drug Administration (FDA) has
FDA Approves Qulipta (atogepant) Oral CGRP Receptor Antagonist for the Preventive Treatment of Migraine
NORTH CHICAGO, Ill., Sept. 28, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Qulipta (atogepant) for the preventive treatment of ep
FDA Approves Opzelura (ruxolitinib) Cream for the Treatment of Atopic Dermatitis (AD)
WILMINGTON, Del.--(BUSINESS WIRE) September 21, 2021 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-t
FDA Grants Accelerated Approval for Tivdak (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer
BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE) September 20, 2021 -- Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA
FDA Approves Byooviz (ranibizumab-nuna), a Biosimilar to Lucentis
INCHEON, Korea and CAMBRIDGE, Mass. – September 20, 2021 -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved Byoov
FDA Approves Exkivity (mobocertinib) for EGFR Exon20 Insertion+ Non-Small Cell Lung Cancer (NSCLC)
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE) September 15, 2021 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administrati
FDA Approves Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine
SEATTLE, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Impel NeuroPharma, Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases
FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021 -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsych
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