Industry News Drugs.com – New Drug Approvals FDA Approves Zycubo (copper histidinate) for Children With Menkes DiseaseJanuary 12, 2026 FDA Approves Nereus (tradipitant) for the Prevention of Motion SicknessDecember 30, 2025 FDA Approves Yartemlea (narsoplimab-wuug) for the Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic MicroangiopathyDecember 24, 2025 FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-ThalassemiaDecember 23, 2025 FDA Approves Furoscix for Use in Pediatric Patients Weighing 43kg or AboveDecember 23, 2025 FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura in Pediatric Patients 12 Years and OlderDecember 23, 2025 FDA Approves Nufymco (ranibizumab-leyk), an Interchangeable Biosimilar to LucentisDecember 23, 2025 FDA Approves Oziltus (denosumab-mobz), a Biosimilar to XgevaDecember 22, 2025 FDA Approves Boncresa (denosumab-mobz), a Biosimilar to ProliaDecember 22, 2025 FDA Approves Extension of the Indication for Accrufer to Include Children 10 Years and Older with Iron DeficiencyDecember 22, 2025 Drugs.com – New Drug Applications FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell TumorJanuary 20, 2026 Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast CancerJanuary 20, 2026 Sebela Pharmaceuticals Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux DiseaseJanuary 12, 2026 Atara Biotherapeutics Provides Regulatory Update on Ebvallo (tabelecleucel)January 12, 2026 Camurus Announces FDA Acceptance of NDA Resubmission for Oclaiz for the Treatment of AcromegalyJanuary 9, 2026 Biosplice Announces the Submission of its New Drug Application (NDA) to the FDA for Lorecivivint (LOR) to Treat Knee OsteoarthritisJanuary 6, 2026 Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV)January 5, 2026 Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with HypercortisolismDecember 31, 2025 Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)December 29, 2025 Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)December 29, 2025 Drugs.com – Clinical Trials News FDA Grants Orphan Drug Designation to BlueRock Therapeutics’ Investigational Cell Therapy OpCT-001January 22, 2026 Opna Bio Announces Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of MyelofibrosisJanuary 21, 2026 Lantern Pharma's LP-284 Receives FDA Orphan Drug Designation for Soft Tissue SarcomasJanuary 20, 2026 Moderna & Merck Announce 5-Year Data for Intismeran Autogene in Combination With Keytruda (pembrolizumab) in Patients With High-Risk Stage III/IV MelanomaJanuary 20, 2026 Lilly's Sofetabart Mipitecan Receives U.S. FDA's Breakthrough Therapy Designation for the Treatment of Certain Patients with Platinum-Resistant Ovarian CancerJanuary 20, 2026 Valneva Announces Voluntarily Withdrawal of Ixchiq (chikungunya vaccine, live) BLA in the U.S.January 19, 2026 Novartis Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren’s DiseaseJanuary 19, 2026 GSK Announces Positive Results from B-Well 1 and B-Well 2 Phase III trials for Bepirovirsen, a Potential First-in-Class Treatment for Chronic Hepatitis BJanuary 7, 2026 Ultragenyx Announces Phase 3 Orbit and Cosmic Results for Setrusumab (UX143) in Osteogenesis ImperfectaDecember 29, 2025 Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential TremorDecember 29, 2025
