cGxP.wire https://validator.w3.org/feed/docs/rss2.html Laminar Completes CLINGLIO Trial Enrollment for LAM561 Harbour BioMed, Sinopharm Form Innovation R&D Consortium argenx SE Expands Immunology Pipeline with Forte Biosciences Deal ArkBio Completes Phase I Dosing of AK0406 Influenza Drug AnHorn Medicines Advances AH-008 into Phase I Trial for CIPN Prevention AnX Robotica Unveils NaviCONNECT Cloud Platform for GI Diagnostics Otsuka Wins FDA Approval for First-in-Class SIMTRIYO for ADHD NewAmsterdam Pharma Wins CHMP Support for Ubeslo® and Evlarco® Zevra Therapeutics to Seek EU Re-Examination for Arimoclomol After CHMP Opinion Advita Ortho Reports First Clinical Use of Activit-E® Humeral Liners Prime Medicine Achieves FDA Milestone for PM577a Kenvue’s Tylenol® Earns FDA Approval for OTC Naproxen Combination Elephas Biosciences Expands elive™ Platform to Targeted Therapies Par Health Launchs First FDA-Approved Generic Janumet® XR in U.S. Accord BioPharma Launches Two Denosumab Biosimilars Royalty Pharma Acquires Cliramitug Royalty Rights from Neurimmune Immutep Announces ESMO 2026 Presentation for EFTISARC-NEO Trial Apertura Joins ARPA-H Program for Rare Gene Therapies SimBioSys, Ferrum Expand AI Breast Surgery Planning Persica Pharmaceuticals Presents New PP353 Data Supporting Non-Opioid Chronic Low Back Pain Treatment FDA Moves to Revoke Two Petroleum-Based Food Color Additives Minoryx Therapeutics Secures CHMP Backing for NEZGLYAL® in cALD 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 Organon Reports Positive Phase 3 VTAMA Data in Atopic Dermatitis Lundbeck Wins FDA Fast Track for Lu AH69593 in Narcolepsy Merck & Co., Inc. Expands Global Access to Once-Monthly Alimatravir Alps Dx Launches Xpressor to Improve Oral Fluid Sample Quality Dassault Systèmes Powers Virtual Twin Factories with AI Agents ARTHEx Biotech Reports ATX-01 DM1 Brain Therapy Progress Daiichi Sankyo and AstraZeneca Win CHMP Backing for Enhertu in HER2-Positive Breast Cancer 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 Outlook Therapeutics Secures FDA Approval for LYTENAVA™ 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