FDA Grants Accelerated Approval for Avlayah (tividenofusp alfa-eknm) for the Treatment of Hunter Syndrome (MPS II)
SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for
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
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