cGxP.wire https://validator.w3.org/feed/docs/rss2.html Ironwood Wins FDA Approval for Pediatric LINZESS Samsung Bioepis Expands Ophthalmology Portfolio with European Launch of OPUVIZ Natera Partners with Diakonos Oncology to Evaluate Signatera in Refractory Melanoma Trial PanTher Advances PTM-101 Into Expansion Phase for Non-Metastatic Pancreatic Cancer Pfizer Reports Landmark Seven-Year LORBRENA Data in Advanced ALK-Positive Lung Cancer BostonGene Highlights AI-Powered Oncology Research at ASCO 2026 Phanes Advances Spevatamig with Encouraging PDAC Data QIAGEN Launches Bundibugyo Ebola Research Assays to Support Outbreak Surveillance Cardiosense Wins FDA De Novo for AI Heart Failure Technology Kelun-Biotech Reports Strong Phase II Data for Lunbotinib Johnson & Johnson Reports Strong Survival Data for RYBREVANT Lupin Receives US FDA EIR for Ankleshwar Manufacturing Site AstraZeneca’s Imfinzi Wins FDA Approval in NMIBC Tonix Highlights Real-World Opioid Burden in Fibromyalgia at ASCP 2026 Parexel Showcases Oncology Research and Patient-Centered Innovation at ASCO 2026 Philips and Disney Transform Pediatric MRI Experience Regeneron’s Ebola Antibody Prioritized by WHO for Bundibugyo Outbreak Research Cogent’s Bezuclastinib Gains FDA Priority Review for GIST Altimmune’s Pemvidutide Shows Strong MASH Phase 2b Data Emergent BioSolutions Secures $64.5M U.S. Contract for BAT® Antitoxin Lilly Unveils Landmark Phase 3 Data for Foundayo and Retatrutide at ADA 2026 AngioDynamics Expands Medicare Access for NanoKnife Cancer Therapy Merck’s Calderasib Earns FDA Breakthrough Therapy Status GSK’s Bepirovirsen Delivers Landmark Phase 3 Cure Data Callio Therapeutics Advances CLIO-8221 Phase 1 Trial for HER2 Tumors Roche Launches AI-Powered Liver Disease Panel for Early Detection Sanofi’s Venglustat Gains FDA Priority Review for GD3 Immunic Presents New Phase 2 Data Supporting Vidofludimus Calcium in Progressive MS Johnson & Johnson Wins FDA Label Expansion for TREMFYA Bridge to Life’s VitaSmart HOPE Boosts Liver Transplant Success Ribo’s RBD1119 Moves Into Phase 2 Development for Coronary Artery Disease Enterome Wins FDA Orphan Tag for EO2463 in iNHL Trogenix Doses First Patient in TGX-007 Glioblastoma Trial Antengene Expands Oncology Pipeline With Phase III ATG-022 Gastric Cancer Trial Biovica’s DiviTum TKa Shows Early Breast Cancer Response Signals Jazz Reports Phase 3 Success for Ziihera in HER2+ GEA Innocan Pharma Reports Strong Q1 Growth and Pipeline Progress Human Longevity and Insilico Launch AI Longevity Platform Leads Biolabs’ Opamtistomig Shows Strong NSCLC Response Ahead of WCLC 2026 Basilea Lands New BARDA Funding for Resistant UTI Antibiotic Pfizer and Innovent Forge $10.5B Global Oncology Alliance Synklino Doses First Patient in Phase 1 SYN002 CMV Trial FDA Grants Priority Review to Zydus Therapeutics’ Saroglitazar for Rare Liver Disease DELFI Diagnostics Secures New York Approval for AI-Powered Lung Cancer Blood Test InnoCare Wins China NDA Acceptance for Orelabrutinib in ITP Anaveon Reports Promising Phase 1 ANV600 Cancer Data at ASCO 2026 Merz Therapeutics Unveils New Insights Into Parkinson’s OFF Episodes at WPC 2026 Natera Begins SIGNAL-ER 101 Trial for MRD-Guided Breast Cancer Therapy HanchorBio Expands Global Growth Strategy With Taiwan Listing and HCB101 Clinical Progress BeOne Medicines Reports Positive Phase 3 HERIZON-GEA Results at ASCO 2026