Industry News Drugs.com – New Drug Approvals U.S. FDA Approves Expanded Indication for Lilly's Jaypirca (pirtobrutinib) for Adults with Relapsed or Refractory CLL/SLLDecember 3, 2025 FDA Approves Armlupeg (pegfilgrastim-unne), a Biosimilar to NeulastaDecember 1, 2025 FDA Grants Accelerated Approval for Voyxact (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A NephropathyNovember 26, 2025 Imfinzi Approved in the US as First and Only Perioperative Immunotherapy for Patients with Early Gastric and Gastroesophageal CancersNovember 25, 2025 FDA Approves Itvisma (onasemnogene abeparvovec-brve) Gene Replacement Therapy for Adults and Children Two Years and Older with Spinal Muscular AtrophyNovember 25, 2025 FDA Approves Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults with Cisplatin-Ineligible Muscle-Invasive Bladder CancerNovember 21, 2025 FDA Approves Jubereq (denosumab-desu), a Biosimilar to XgevaNovember 20, 2025 FDA Approves Osvyrti (denosumab-desu), a Biosimilar to ProliaNovember 20, 2025 FDA Grants Accelerated Approval to Hyrnuo (sevabertinib) for Non-Squamous Non-Small Cell Lung CancerNovember 20, 2025 Eylea HD (aflibercept) Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved IndicationsNovember 19, 2025 Drugs.com – New Drug Applications Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion SicknessNovember 28, 2025 Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast CancerNovember 17, 2025 Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA NephropathyNovember 7, 2025 FDA Issues Complete Response Letter for Biohaven's Vyglxia (troriluzole) New Drug Application for Spinocerebellar AtaxiaNovember 5, 2025 Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced MelanomaOctober 20, 2025 Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)October 13, 2025 Sentynl Therapeutics Updates On Its NDA for CUTX-101October 1, 2025 Novo Nordisk Resubmits Awiqli to the FDA with Potential to be the First Once-Weekly Basal Insulin Treatment for Adults with Type 2 DiabetesSeptember 29, 2025 FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish FacilitySeptember 23, 2025 FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian CancerSeptember 10, 2025 Drugs.com – Clinical Trials News Belite Bio Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt DiseaseDecember 1, 2025 U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell LymphomaNovember 26, 2025 Novo Nordisk Phase 2 Trial with Amycretin Reports Significant Weight Loss and HbA1c Reduction in Type 2 DiabetesNovember 25, 2025 Evoke Phase 3 Oral Semaglutide Trials Did Not Demonstrate a Statistically Significant Reduction in Alzheimer's Disease ProgressionNovember 24, 2025 Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke PreventionNovember 23, 2025 Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults with HIV-1 InfectionNovember 19, 2025 Novo Nordisk Launches Introductory Self-Pay Offer for Wegovy and Ozempic for $199 per MonthNovember 17, 2025 Genentech’s Giredestrant Becomes the First Oral SERD to Show Superior Invasive Disease-Free Survival in Early Breast CancerNovember 17, 2025 FDA Grants Fast Track Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric CancerNovember 17, 2025 Update on Phase 3 Librexia ACS Trial of MilvexianNovember 14, 2025
