FDA Approves Lifyorli (relacorilant) Plus Nab-Paclitaxel for the Treatment of Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE) -- Mar. 25, 2026 -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat

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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

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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

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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

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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

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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

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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

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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

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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

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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:

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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

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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

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