Tuesday, November 18, 2025

FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria

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PTC Therapeutics, Inc. (NASDAQ: PTCT) announced  the U.S. Food and Drug Administration (FDA) approval of  Sephience™ (sepiapterin) for the t...
Friday, November 14, 2025

FDA Approves Yutrepia (treprostinil) Inhalation Powder for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

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Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary dise...
Thursday, November 13, 2025

FDA Approves Brekiya (dihydroergotamine mesylate) Injection for the Acute Treatment of Migraine and Cluster Headaches in Adults

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Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”)  announced  the U.S. Food and Drug Administration (FDA) approval of ...
Wednesday, November 12, 2025

FDA Grants Accelerated Approval to Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib tablets) for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

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Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven...
Tuesday, November 11, 2025

FDA Approves Ctexli (chenodiol) for Cerebrotendinous Xanthomatosis

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Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM)  announced the  U.S. Food and Drug Administration (FDA) approval of  Ctexli™ (chenodiol) tablets,...
Monday, November 10, 2025

FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor

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Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced  the U.S. Food and Drug Administration ...
Friday, November 7, 2025

FDA Approves Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, anno...
Thursday, November 6, 2025

FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections

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In continuation of update on avibactam   aztreonam avibactam AbbVie (NYSE: ABBV)   announced   the U.S. Food and Drug Administration (FDA)  ...
Tuesday, November 4, 2025

FDA Approves Onapgo (apomorphine hydrochloride) for the Treatment of Motor Fluctuations in Adults with Advanced Parkinson’s Disease

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Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatm...
Monday, November 3, 2025

FDA Approves Journavx (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)   announced   U.S. Food and Drug Administration (FDA)   approval of  Journavx (suzetrigin...
Friday, October 31, 2025

FDA Approves Subvenite (lamotrigine) Oral Suspension for Epilepsy and Bipolar Disorder

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OWP Pharmaceuticals announced the U.S. Food and Drug Administration (FDA)  approval of  Subvenite Oral Suspension, the first and only lamotr...