Industry News Drugs.com – New Drug Approvals U.S. Food and Drug Administration Approves Perioperative Treatment of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable Non-Small Cell Lung Cancer (NSCLC)October 3, 2024 FDA Approves Otulfi (ustekinumab-aauz), a Biosimilar to StelaraSeptember 30, 2024 Dupixent Approved in the US as the First-Ever Biologic Medicine for Patients with COPDSeptember 27, 2024 FDA Approves Flyrcado (flurpiridaz F 18) Radioactive Diagnostic for Enhanced Diagnosis of Coronary Artery DiseaseSeptember 27, 2024 FDA Approves Cobenfy (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in AdultsSeptember 27, 2024 FDA Grants Traditional Approval to Retevmo (selpercatinib) for Medullary Thyroid Cancer with a RET MutationSeptember 27, 2024 Tagrisso Approved in the US for Patients with Unresectable, Stage III EGFR-Mutated Lung CancerSeptember 26, 2024 FDA Approves Aqneursa (levacetylleucine) for the Treatment of Niemann-Pick Disease Type CSeptember 25, 2024 UCB Announces U.S. FDA Approvals for Bimzelx (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis and Ankylosing SpondylitisSeptember 23, 2024 Sarclisa Approved in the US as the First Anti-CD38 Therapy in Combination with Standard-of-Care Treatment for Adult Patients with Newly Diagnosed Multiple Myeloma Not Eligible for TransplantSeptember 20, 2024 Drugs.com – New Drug Applications Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye DiseaseOctober 3, 2024 Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival AnalysisSeptember 23, 2024 FDA Declines to Approve Vanda's Marketing Application for Tradipitant in GastroparesisSeptember 19, 2024 Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of MigraineSeptember 4, 2024 KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary AngioedemaSeptember 3, 2024 Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on DialysisSeptember 3, 2024 Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia GravisAugust 29, 2024 Telix Submits NDA for TLX101-CDx (Pixclara) Brain Cancer Imaging AgentAugust 28, 2024 FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PNAugust 28, 2024 Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi SyndromeAugust 27, 2024 Drugs.com – Clinical Trials News First Patients Dosed in Phase 1a/b Clinical Trial of RGT-61159, an Oral Small Molecule Targeting MYB, in Adenoid Cystic Carcinoma and Colorectal CancerOctober 8, 2024 First Patient Dosed in Clinical Study of PT886 in Combination with KeytrudaOctober 8, 2024 TCI Unveils Promising GLP-1 Formula Clinical Trial Results for Advanced Weight ManagementOctober 7, 2024 First Healthy Volunteer Dosed with HT-4253, a Novel Oral LRRK2 Inhibitor Targeting Neuroinflammation in Alzheimer's DiseaseOctober 7, 2024 Trevi Therapeutics Provides Update on Haduvio's Clinical Development ProgramOctober 3, 2024 ERLEADA demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancerOctober 2, 2024 Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited CountriesOctober 2, 2024 Eirion Therapeutics Announces Results of First-in-Human Clinical Trial Evaluating Ready-to-Use Liquid Injectable Neuromodulator AI-09 for the Treatment of WrinklesOctober 2, 2024 Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASHOctober 1, 2024 Thryv Therapeutics Granted FDA Orphan Drug Designation for LQT-1213 in Long QT Syndrome TreatmentOctober 1, 2024
