cGxP.wire https://validator.w3.org/feed/docs/rss2.html Lundbeck Gains FDA Orphan Drug Status for Asedebart Nutromics Receives FDA Breakthrough Device Designation NRx Pharmaceuticals Deploys Robotic TMS Across HOPE Clinics Breakthrough T1D Publishes Global Screening Guidance Adneuris Advances Cebranopadol Toward Acute Pain NDA Avance Clinical Wins Australia-Taiwan Business Award IMUNON and NCI Advance IMNN-001 Clinical Development Lyell Immunopharma Completes LYL273 Manufacturing Transfer Ocumension Therapeutics Advances OT-301 in China Persica Pharmaceuticals Strengthens PP353 Rationale in Lumbar Back Pain Resolution Therapeutics Completes RTX001 EMERALD Enrollment Crossbow Therapeutics Doses First Patient in CBX-663 Phase 1 TwoStep Therapeutics Secures $62.5M and FDA IND Clearance CU Anschutz Wins FDA Clearance for CAR T Cancer Trial Johnson & Johnson Gains CE Mark for ACUVUE OASYS MAX Cardiol Therapeutics Files US$150M Shelf Prospectus Emulate Advances FDA Qualification for Human Liver-Chip Seaport Therapeutics Reports Positive Phase 1 GlyphAllo Data Bayer Wins FDA Accelerated Approval for Sevabertinib Ethris and EIB Sign €30M Financing for Antiviral Genentech Gains FDA Priority Review for Enspryng in MOGAD Compass Pathways Names U.S. Grant Recipients for COMP360 Training Definium Therapeutics to Present Phase 3 DT120 Data at Psych Congress Prelude Therapeutics Gains FDA Clearance for PRT13722 Adagene and Third Arc Bio Select First Lead Candidate Consano Bio Reports C-1101 Data in Chronic Sciatica UpDoc Leads ARPA-H Program for Clinical AI Care AdJane Unveils mRNA Mucosal Booster Vaccine Strategy 1cBio and Lee’s Pharm Partner on PARP1 Inhibitor OC-3 Full-Life Technologies Advances FL-261 to Phase 1 CONNECTA Therapeutics Secures €3.1M for Fragile X Program Teitur Trophics Advances TT-P34 Toward Phase II in Parkinson’s EPIK Biosciences Expands Ketamine and DXM Drug Portfolio Disc Medicine Advances DISC-3405 in Polycythemia Vera BioLineRx and Hemispherian Present GLIX1 Data Roche Wins FDA Priority Review for Enspryng in MOGAD Compass Pathways Advances COMP360 Toward Potential TRD Launch GSK Shingrix Prefilled Syringe Approved in Japan Insilico Doses First Patient in AI-Driven Phase 3 IPF Trial Schrödinger Launches Tectora With $55 Million Series A IDEAYA and Servier Launch Phase 3 Uveal Melanoma Trial Tyra Reports Phase 2 Dabogratinib Results in Bladder Cancer Seaport Therapeutics Advances GlyphAllo in Major Depression Marengo Completes STARt-001 Enrollment, Strengthens Team Bayer Advances GIRK4 Inhibitor Into Phase II for Atrial Fibrillation Harbour BioMed Partner Solstice Oncology Raises $225M Cocrystal Pharma Advances CDI-988 in Norovirus Challenge Study Beeline Medicines Advances Afimetoran Toward Pivotal Lupus Trials MetaVia Reports Preclinical Data on DA-1726 Waist Reduction Kazia Doses First Patient in Pediatric AT/RT Study