FDA Grants Accelerated Approval to Loargys (pegzilarginase-nbln) for the treatment of Hyperargininemia in Patients with Arginase 1 Deficiency
STOCKHOLM, Sweden and CHICAGO, Illinois - February 23, 2026 - Immedica Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys® (pegzilargin
FDA Approves Bysanti (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia
February 20, 2026 WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti (milsaperido
FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis
East Windsor, NJ - February 13, 2026 - Acrotech Biopharma Inc., a bio-pharmaceutical company focused on developing and commercializing innovative propriety medications, in collaboration with Otsuka Ph
FDA Approves Filkri (filgrastim-laha), a Biosimilar to Neupogen
January 15, 2026 -- The U.S. Food and Drug Administration has approved Filkri (filgrastim-laha), a biosimilar to Neupogen from Accord BioPharma, Inc. Filkri is a leukocyte growth factor indicated to:
FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat Presbyopia
LONDON, U.K. and SEATTLE, Wash., January 28, 2026 -- Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the ag
FDA Approves Zycubo (copper histidinate) for Children With Menkes Disease
January 12, 2026 -- The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action
FDA Approves Nereus (tradipitant) for the Prevention of Motion Sickness
WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration has approved Nereus (tradipitant), an oral neurok
FDA Approves Yartemlea (narsoplimab-wuug) for the Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy
SEATTLE--(BUSINESS WIRE)--Dec. 24, 2025 -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab-wuug) for the treatmen
FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia
CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients wit
FDA Approves Myqorzo (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamt
FDA Approves Boncresa (denosumab-mobz), a Biosimilar to Prolia
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership
FDA Approves Oziltus (denosumab-mobz), a Biosimilar to Xgeva
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership
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