cGxP.wire https://validator.w3.org/feed/docs/rss2.html Apertura Joins ARPA-H Program for Rare Gene Therapies SimBioSys, Ferrum Expand AI Breast Surgery Planning Momentis Surgical’s Anovo Becomes First Triple-Approach Robot MolecuLight Reports First Clinical Evidence for Fluorescence Imaging VELMENI Secures FDA 510(k) for AI-Powered 3D CBCT Imaging Eli Lilly Reports Positive Phase 3 Retatrutide Results Johnson & Johnson Advances Myeloma Care with TECVAYLI and TALVEY Laminar Completes CLINGLIO Trial Enrollment for LAM561 ArkBio Completes Phase I Dosing of AK0406 Influenza Drug Otsuka Wins FDA Approval for First-in-Class SIMTRIYO for ADHD Organon Reports Positive Phase 3 VTAMA Data in Atopic Dermatitis Prime Medicine Achieves FDA Milestone for PM577a Lundbeck Wins FDA Fast Track for Lu AH69593 in Narcolepsy Daiichi Sankyo and AstraZeneca Win CHMP Backing for Enhertu in HER2-Positive Breast Cancer Merck & Co., Inc. Expands Global Access to Once-Monthly Alimatravir Royalty Pharma Acquires Cliramitug Royalty Rights from Neurimmune ARTHEx Biotech Reports ATX-01 DM1 Brain Therapy Progress Align Technology Unveils AI-Powered Invisalign Digital Platform AstraZeneca’s Etcamah Approved for First-Line Breast Cancer Gilead Sciences Secures CHMP Support for Trodelvy Plus KEYTRUDA Repligen’s $1.5B BioLife Deal Expands CGT Portfolio Atsena Therapeutics Secures EMA Orphan Status for Two Gene Therapies HCW Biologics Reaches FDA Pre-IND Milestone for HCW11-018b Inhibikase Gains FDA Orphan Drug Status for IKT-001 in PAH Genmab and AbbVie Clarify EPCORE DLBCL-1 Phase 3 Results MacroGenics Reports Positive Phase 1 MGC026 Cancer Study Update Ipsen Announces Phase III BOLD Results for Bylvay in Biliary Atresia Sanofi Ends Amlitelimab Development for Atopic Dermatitis Roche’s Susvimo Receives Positive CHMP Opinion for EU Approval Cosmetic Physician Partners Returns $35 Million to Employee Owners Nona Biosciences and MedUni Vienna Collaborate on Infectious Diseases Nuvectis Pharma Announces China Approval of Ciprocopan for PNH GHIT Fund Accelerates Portable Ebola Diagnostic Innovation Autonomix Medical Secures New U.S. Patent for Precision Neuromodulation Platform Verastem Oncology Doses First Patient in Phase 2 VS-7375 NSCLC Trial Penumbra THUNDERBOLT Shows Strong Stroke Trial Results Pfizer Inc. Wins FDA Priority Review for Prostate Cancer Therapy Xodus Medical Study Validates Hot Pink Pad Performance Dexcom Selected as First Participant in FDA TEMPO Pilot Program GSK Wins FDA Approval for Jideytro in ROS1+ Lung Cancer Ibex Medical Analytics Strengthens Breast Cancer AI with CE-IVDR Approval Ribo Unveils Positive Phase 2a Data for Vortosiran in CAD BeOne Medicines Scales Cancer Drug Production in the U.S. Ascletis Reports Superior ASC36_35 Weight Loss Data at EASD 2026 Azafaros Finishes Patient Enrollment in NAVIGATE Phase 3 Trial Lakewood-Amedex Highlights Nu-3 Against Antibiotic Resistance LB Pharmaceuticals Accelerates Phase 3 LB-102 Schizophrenia Timeline Artelo Biosciences Advances ART12.11 Following CBD Research Review Co-Diagnostics Targets India TB Diagnostics with PCR Pro Studies BridgeBio Announces FDA Acceptance of Encaleret NDA for ADH1