cGxP.wire https://validator.w3.org/feed/docs/rss2.html Thermo Fisher Opens US Bioprocess Center to Boost Biologics Paradigm Health, FDA Advance Real-Time Trial Review Model AcuraStem Secures $7.5M to Advance AS-241 for ALS and FTD Earflo Wins FDA Clearance for Pediatric Ear Device Telix Advances TLX597-Tx Phase 2 Prostate Cancer Program Olympus Gains FDA Clearance for POWERSEAL Open Device Profluent, Lilly Partner to Advance AI Gene Editing Tech PreludeDx Secures FDA Breakthrough for AidaBREAST Test Mesoblast Completes Enrollment in Pivotal Phase 3 Trial for Chronic Low Back Pain Kestrel Therapeutics Doses First Patient in KRAS Trial CareDx Acquires Naveris to Expand Precision Oncology EnteroBiotix Secures £19M for Phase 2b IBS-C Trial Vanda Pharma Publishes Phase III Imsidolimab Data HUTCHMED Advances Sovleplenib NDA for wAIHA in China Teva Pharmaceutical Acquires Emalex to Advance Tourette Therapy Henlius and Organon Secure EU Approval for POHERDY® BRC Therapeutics Secures FDA IND Clearance for BRC-002 Therapy BioLineRx & Hemispherian Dose First Patient in GLIX1 GBM Trial InnoCare Advances Phase III Orelabrutinib Trial for SLE Latus Bio Advances Gene Therapy Programs for Rare CNS Diseases Affinia Therapeutics Advances AFTX-201 for BAG3 DCM Orca Bio Secures FDA RMAT Status for Orca-Q Therapy AstraZeneca Breztri Becomes First Triple Therapy Approved for Asthma in US GSK Bepirovirsen Wins FDA Priority Review Breakthrough Status Avenzo Therapeutics Advances Dual CDK Inhibitor Breast Cancer Study Abbott Ultreon 3.0 AI Imaging Gains FDA, CE Approval Quoin Pharmaceuticals Expands QRX009 Topical Rapamycin Pipeline Pixee Medical Knee+ NexSight Wins FDA 510(k) Clearance PharmaLogic Opens PET Radiopharma Facility in Atlanta IGC Pharma Strengthens CALMA Trial Through Caregiver Outreach MediciNova Advances Brain Metastasis Therapy With MN-166 Sapient Launches Tumor Protein Mapping Platform for Oncology Taiho Zipalertinib NDA Accepted by FDA for NSCLC VectorY Therapeutics Secures EMA and MHRA Approval for VTx-002 Trial SQ Innovation Lasix ONYU Gains CE Mark EMA Review Scancell Advances Cancer Immunotherapy Pipeline Momentum Mirai Bio Advances Targeted LNP Delivery at ASGCT Sail Biomedicines Advances In Vivo eRNA CAR-T Data Encoded Therapeutics Showcases ETX101 Data at ASGCT Boehringer Survodutide Shows 16.6% Weight Loss in Phase III Elanco Secures EUA for Screwworm Treatment in Livestock Fathom Therapeutics Raises $47M to Advance AI Drug Design Ferrotec Introduces Ferrobeads for High-Efficiency DNA RNA Isolation Zentiva Appeals EU Wastewater Directive Impact on Pharma AVITA Medical Secures TGA Approval for RECELL GO in Australia Cellenkos Wins FDA Clearance for CK0801 Phase 2 Trial Galaxy Therapeutics Submits PMA for SEAL Device FDA Johnson & Johnson Strengthens CNS Portfolio with CAPLYTA FDA Nod Apotex Secures FDA Approval for Infuvite Pediatric Injection Aidoc Secures $150M Led by Goldman Sachs for AI Growth