cGxP.wire https://validator.w3.org/feed/docs/rss2.html 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 U.S. Renal Care Expands Advanced HDx Dialysis Access Nitinotes Advances EndoZip With First Orlando Health Procedures Nabsys Partners With Indiana University on Cancer Genomics Lupin Expands U.S. Portfolio With FDA-Approved Sugammadex Aspen Neuroscience Wins FDA RMAT Designation for ANPD001 Ractigen’s RAG-1C Wins FDA IND Clearance for PVR NIPRO Wins FDA Clearance for ELISIO-HX Expanded HD Dialyzer Ractigen Therapeutics Closes $31M Financing to Advance saRNA Pipeline Hippocratic AI Launches Rapid Response Climate Agents for Healthcare Karyopharm Eyes Accelerated FDA Approval for Selinexor Cytokinetics Wins UK Approval for MYQORZO in oHCM Amgen’s Repatha Wins CHMP Support for Broader Heart Protection Kaigene, Taisho Advance KG006 Autoimmune Therapy Deal Italfarmaco Secures Managed Entry Agreement for Duvyzat in Georgia 10x Genomics, CHUV Advance Precision Cancer Diagnostics Tiziana Life Sciences Reports Positive Foralumab Data in Third MSA Patient CREATE, Monash Partner to Advance In Vivo CAR-T Platform Ratio Therapeutics Raises $70 Million to Advance Radiotherapeutics Contineum Therapeutics Affirms Phase 2 Milestones and Cash Runway Curis Advances TakeAim CLL Trial with First Patients Dosed Amplia Therapeutics Reports Promising Preclinical Narmafotinib Data in Pancreatic Cancer EVERSANA, Innovacell Partner to Advance ICEF15 Cell Therapy Moleculin Reports Positive Interim MIRACLE Trial Data in Venetoclax-Failed AML Patients Daiichi Sankyo and AstraZeneca Receive EU Approval for Datroway in First-Line Metastatic TNBC CREATE Launches First Human Trial of In Vivo CAR-T Therapy Fresenius Kabi’s Vedolizumab Biosimilar Accepted for FDA and EMA Review Polpharma Biologics Secures FDA and EMA Review for PB016 Aravax Wins FDA Fast Track Designation for PVX108 Novo Nordisk Reports ZEUS Phase 3 Results for Ziltivekimab Medicus Pharma Receives UAE IND Authorization for PRECISION-E2 Study Abivax Aligns with FDA on Obefazimod NDA Submission Basking Reports BB-031 Stroke Therapy Preclinical Breakthrough Supernus Pharmaceuticals and Indivior to Merge in $2.2 Billion CNS Biopharma Deal