cGxP.wire https://validator.w3.org/feed/docs/rss2.html Roivant Wins FDA Approval for LISRAYA in Dermatomyositis Protagonist Therapeutics Wins FDA Approval for MIMRYLO Tenax Therapeutics Reports LEVEL Data at ESC Congress 2026 Cytokinetics Highlights Phase 3 Aficamten Data at ESC Bristol Myers Squibb Reports Five-Year Camzyos Data BridgeBio Pharma Reports New Acoramidis Data at ESC 2026 Alnylam Presents ATTR-CM Data at ESC Congress 2026 Takeda Wins FDA Approval for MIMRYLO in Polycythemia Vera Arrowhead Reports Phase 3 Plozasiran Data Reducing Pancreatitis HUTCHMED Reports Phase III SANOVO PFS Benefit in EGFR NSCLC Priovant Reports Skin Benefits of Brepocitinib in Phase 3 Natera Partners With Susan G. Komen to Advance Breast Cancer Awareness Acadia Pharmaceuticals’ DAYBU Approved in EU for Rett Syndrome Shionogi Expands Fetroja Role in U.S. Drug-Resistance Preparedness CRISPR Therapeutics Reports Durable CTX310 Lipid Lowering Roche Wins FDA Clearance for Elecsys pTau217 Test United Therapeutics Advances PAH and IPF Data at ESC, ERS Takeda Wins Japan Approval for ORZEYFUL in Narcolepsy GSK Wins Japan Approval for Hibsago in Hepatitis B Agenus Reports Durable BOT+BAL Activity in MSS Colorectal Cancer Amarin Reports Potential Legacy Effect of Icosapent Ethyl in New REDUCE-IT Analysis Teva Bids for BioXcel’s BXCL501 in Potential At-Home Agitation Treatment Deal United Therapeutics’ Ralinepag NDA Accepted by FDA Zambon Announces European Commission Approval of Hopledo for Parkinson’s Disease Motor Fluctuations Orsini Partners With Priovant to Support LISRAYA Access BioLineRx Raises $3.75M to Advance Oncology Pipeline Formosa Pharmaceuticals Files CTA for TSY-110 Verrica Advances YCANTH Toward Potential FDA Approval for Common Warts Asieris Advances Biopharma Pipeline and CEVIRA Launch Nicox Sets April 2027 FDA Decision Date for NCX 470 Quoin Pharmaceuticals Reports Positive Interim Phase 2/3 Data for QRX003 in Netherton Syndrome Samsung Biologics Plans KRW 3 Trillion Rights Offering Roche’s Vabysmo Enables Extended 20-Week Dosing in PCV Patients Rectify Advances RTY-406 as Potential Disease-Modifying Therapy for PSC Catheter Precision Secures LockeT Orders and First German VIVO Placement DualityBio and Genentech Partner on Next-Gen ADCs Leo Cancer Care and GE HealthCare Advance Radiation Therapy InxMed Reports Positive Phase Ib/II Data for Ifebemtinib Lilly’s Mounjaro Gains FDA Approval for Heart Risk Reduction GE HealthCare Advances Cardiac Ultrasound With AI-Enabled Vivid Imaging Systems Cardurion Announces Late-Breaking Phase 2 Tovinontrine Results in Heart Failure MBX Biosciences Doses First Patient in Phase 3 oPTimize Trial of Canvuparatide AES Cleanroom Technology Gains FM 4882 Approval CytomX Wins FDA Fast Track Designation for Varseta-M in Metastatic Colorectal Cancer Propanc Advances PRP After Strong Preclinical Pancreatic Cancer Results Fresenius Medical Care Reports Lower Mortality With HDF Pillar Biosciences Expands Automated NGS Cancer Workflow Priovant Wins FDA Approval for Lisraya in Dermatomyositis argenx Completes Forte Biosciences Acquisition for FB102 CREATE Medicines, WestGene Expand In Vivo CAR Programs