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FDA Approves Lynavoy (linerixibat) for Cholestatic Pruritus in Patients with Primary Biliary Cholangitis

London, UK 19 March 2026 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult

FDA Approves Icotyde (icotrokinra) for the Treatment of Plaque Psoriasis

SPRING HOUSE, Pa. (March 18, 2026) -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Icotyde (icotrokinra), an interleukin-23 (IL-23) r

FDA Grants Accelerated Approval to Yuviwel (navepegritide) for Children with Achondroplasia

COPENHAGEN, Denmark, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accele

FDA Approves Desmoda (desmopressin acetate) Oral Solution for Central Diabetes Insipidus

DEER PARK, Ill., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing tr

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