Industry News Drugs.com – New Drug Approvals Novo Nordisk Introduces Ozempic Pill; Available in the US Q2 2026February 4, 2026 FDA Approves Yuvezzi (carbachol and brimonidine tartrate) Ophthalmic Solution to Treat PresbyopiaJanuary 28, 2026 Darzalex Faspro-Based Quadruplet Regimen Approved for Newly Diagnosed Patients with Multiple Myeloma who are Transplant IneligibleJanuary 27, 2026 MannKind Announces FDA Approval of Updated Afrezza Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime TherapyJanuary 26, 2026 Organon Announces US FDA Approval of Supplemental New Drug Application Extending Duration of Use of Nexplanon (etonogestrel implant) for Up to Five YearsJanuary 16, 2026 FDA Approves Filkri (filgrastim-laha), a Biosimilar to NeupogenJanuary 15, 2026 FDA Approves Zycubo (copper histidinate) for Children With Menkes DiseaseJanuary 13, 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 Drugs.com – New Drug Applications Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for AnaphylmFebruary 2, 2026 Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and AdultsJanuary 27, 2026 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 Drugs.com – Clinical Trials News Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy ProgramFebruary 4, 2026 Pfizer’s Ultra-Long-Acting Injectable GLP-1 RA PF’3944 Shows Robust and Continued Weight Loss with Monthly Dosing in Phase 2b TrialFebruary 3, 2026 Sanofi’s Venglustat Met All Primary Endpoints in a Phase 3 Study of Type 3 Gaucher DiseaseFebruary 2, 2026 CagriSema Demonstrated Superior HbA1c Reduction of 1.91%-Points and Weight Loss of 14.2% in Adults with Type 2 Diabetes in the REIMAGINE 2 TrialFebruary 2, 2026 RegenxBio Announces Regulatory Update on Ultra Rare MPS Programs RGX-111 and RGX-121January 28, 2026 Boehringer Ingelheim’s Investigational Asset Apecotrep Delivers Proteinuria Reduction in Phase II Kidney TrialJanuary 28, 2026 Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment OptionsJanuary 28, 2026 Genentech Announces Positive Phase II Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People Living With ObesityJanuary 26, 2026 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
