Industry News Drugs.com – New Drug Approvals FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory PapillomatosisOctober 30, 2026 Ilumya (tildrakizumab-asmn) Approved in the U.S. for the Treatment of Adults with Active Psoriatic ArthritisOctober 30, 2026 FDA Approves Lucamzi (ranibizumab-blrz), a Biosimilar to LucentisOctober 27, 2026 Pfizer’s Talzenna Plus Xtandi FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment SettingOctober 26, 2026 Novo’s Awiqli Receives FDA Approval as the First and Only Once-Weekly Insulin for Children 10 Years of Age and Older with Type 2 DiabetesOctober 23, 2026 FDA Approves Subcutaneous Induction Regimen for AbbVie's Skyrizi (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's DiseaseOctober 23, 2026 BioCryst Announces U.S. FDA Approval of Orladeyo 150 mg Oral Pellets for Adults and Adolescents with HAEOctober 21, 2026 Ultomiris Received Accelerated Approval in the US as First and Only C5 Complement Inhibitor to Reduce Proteinuria in Adults with Primary Immunoglobulin A NephropathyOctober 21, 2026 FDA Approves Hibsago (bepirovirsen) for the Treatment of Chronic Hepatitis BOctober 20, 2026 Cosette Pharmaceuticals Announces FDA Approval of Evoxac (cevimeline HCl) Oral SolutionOctober 20, 2026 Drugs.com – New Drug Applications uniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for Ifezuntirgene Inilparvovec for the Treatment of Huntington’s DiseaseNovember 2, 2026 Orexo Announces FDA Acceptance of Izipry™ NDA Resubmission for ReviewOctober 29, 2026 Rafael Holdings Announces Submission of New Drug Application to FDA for Trappsol® Cyclo™ (remibetadex) for the Treatment of Niemann-Pick Disease Type COctober 29, 2026 Alume Biosciences Announces FDA Acceptance of New Drug Application for Bevonescein for Use During SurgeryOctober 28, 2026 AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple MyelomaOctober 27, 2026 Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027October 21, 2026 UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBCOctober 19, 2026 Aquestive Therapeutics Announces FDA Acceptance of Anaphylm NDA ResubmissionOctober 15, 2026 Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib for Use as a First-line Treatment Option for Unresectable or Metastatic Hepatocellular CarcinomaOctober 14, 2026 Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug AdministrationOctober 14, 2026 Drugs.com – Clinical Trials News Acumen Pharmaceuticals Announces Topline Results from Phase 2 ALTITUDE-AD Clinical Trial of Sabirnetug (ACU193) for the Treatment of Early Alzheimer’s Disease; Trial Did Not Meet Primary EndpointOctober 30, 2026 HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Primary Immune ThrombocytopeniaOctober 29, 2026 Lilly's Retatrutide Delivered Greater A1C Reduction and More Than Double the Weight Loss of Ozempic's Highest Approved Dose in Head-to-Head TrialOctober 28, 2026 Sacituzumab Tirumotecan (Sac-TMT) Reduced the Risk of Death by 32% and the Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Certain Patients With Advanced or Recurrent Endometrial CancerOctober 26, 2026 Izalontamab Brengitecan (Iza-Bren) Doubles Median Progression-Free Survival in Patients with Previously-Treated EGFR-Mutated Non-Small Cell Lung Cancer Compared to Chemotherapy in the Phase 3 PANKU-Lung01 StudyOctober 26, 2026 Eledon Pharmaceuticals Presents Phase 2 BESTOW Trial Data Showing Sustained Improvements in Quality of Life and Symptom Burden with Tegoprubart Compared to TacrolimusOctober 26, 2026 New Data on Lilly's Investigational Treatment Olomorasib at ESMO 2026 Show Durable First-Line Activity in KRAS G12C-Mutant Non-Small Cell Lung CancerOctober 25, 2026 Genentech’s Divarasib Demonstrated Best-In-Class Efficacy, Advancing the Standard of Care in Previously Treated KRAS G12C-Mutated Lung CancerOctober 25, 2026 Johnson & Johnson Reports 75% Tumor Response Rate in Advanced Prostate Cancer with JNJ-6143, a First-in-Class RIPTAC™ MoleculeOctober 25, 2026 BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus ChemotherapyOctober 25, 2026
