cGxP.wire https://validator.w3.org/feed/docs/rss2.html AIM ImmunoTech Advances DURIPANC Trial with Final Dosing Milestone InnoCare Secures China Breakthrough Therapy Status for Marginal Zone Lymphoma Therapy Candel Therapeutics Announces Extended Phase 3 Data Presentation at ASTRO 2026 Design Therapeutics Reports RESTORE-FA Progress and Advances GeneTAC® Pipeline Altimmune Initiates PERFORMA Phase 3 Trial of Pemvidutide for MASH Zevra Therapeutics Publishes Four-Year MIPLYFFA Real-World NPC Data Meitheal Gains FDA Approval for Garzulys Insulin Biosimilar Rocket Pharmaceuticals Reports Positive RP-A501 Safety Update Zai Lab Receives FDA Orphan Drug Designation for Zoci Seaport Therapeutics Reports Q2 Progress Across Neuropsychiatry Pipeline Biocon Launches Yesafili Biosimilar to Eylea in U.S. Can-Fite Launches Phase 2 Piclidenoson Trial for Lowe Syndrome Akebia Launches Phase 2 Ebribafusp Trial in Kidney Diseases Opus Genetics Completes Enrollment in OPGx-LCA5 Phase 3 Trial Intelligent Bio Solutions Advances FDA 510(k) Drug Screening Study Tonix Pharmaceuticals Receives FDA Alignment for TNX-4800 Phase 2 Trial Adlai Nortye Receives HREC Approval for AN4035 Phase I Trial Genprex and Roche Diagnostics Advance TROP2 Biomarker Strategy Ceribell Secures CMS NTAP for Delirium Monitor System Keenova Publishes New XIAFLEX Data in Peyronie’s Disease Acurx Gains FDA Guidance for Ibezapolstat Phase 3 Program Ceruvia Advances BOL-148 Into Phase 1/2 Cluster Headache Trial Signant Health Introduces Agentic AI for Clinical Trial Supply Lilly’s Olomorasib Earns FDA Breakthrough Therapy Designation Fresenius Kabi Gains FDA Approval for Rituximab Biosimilar Invenio Imaging Completes Enrollment in AI Lung Cancer Study Specialised Therapeutics Expands Minjuvi Access in Australia GlycoNex Doses First Patient in Phase I Trial of GNX1021 AusperBio Doses First Patient for AHB-171 HBV Clinical Study Ascletis Launches Global Phase III Trial of Oral GLP-1 ASC30 Supernus Pharmaceuticals and Indivior to Merge in $2.2 Billion CNS Biopharma Deal Aravax Wins FDA Fast Track Designation for PVX108 IMPACT Therapeutics Names IMP3201 First Dual-Payload ADC Candidate Oculis Achieves Positive FDA Pre-IND Outcome for Privosegtor Program IMPACT Therapeutics Licenses Senaparib to Pharmanovia enVVeno Medical Advances FDA Pivotal Trial for enVVe System Leads Biolabs Completes Opamtistomig Phase II Enrollment in BTC FDA Licenses First-Ever Freeze-Dried Plasma Product in U.S. Leads Biolabs Gains China IND for Opamtistomig in mCRC Avenda Health Expands Unfold AI Across Prostate Cancer Care Novartis’ Pluvicto Wins FDA Approval for Earlier Prostate Cancer Treatment Trace Biosciences and Axogen Advance Nerve Trace Technology Victory Square Updates Hydreight After FDA Peptide Panel Vote Total Flow Medical TFA Cannula Secures FDA 510(k) Clearance Andor Health’s ThinkAndor Advances AI-Native Connected Care Replimune’s RP1 Gains FDA Panel Support for Advanced Melanoma Hansoh Pharma’s Ris-Rez Succeeds in Phase 3 Osteosarcoma Trial FibroBiologics Advances CYWC628 Phase 1/2 Wound Trial Johnson & Johnson Advances RYBREVANT for Head and Neck Cancer Nitinotes Advances EndoZip With First Orlando Health Procedures