cGxP.wire https://validator.w3.org/feed/docs/rss2.html Whitehawk Therapeutics’ PTK7 Data Support ADC Development Telomir Advances Telomir-Zn in Human and Canine Osteosarcoma Bright Path Labs Receives FDA AMT Designation for Medicines Armata’s AP-SA02 Receives FDA Breakthrough Designation Evaxion Expands AI-Immunology Platform Into Autoimmune Disease Santa Ana Bio Advances SAB01 Into Phase 1 Tris Pharma Expands QuilliChew ER With 30-Count Bottle Tenaya Therapeutics Gains RMAT Designation for TN-401 Sanofi and Cheplapharm Form Strategic Mature Medicines Partnership Biofrontera Gains FDA Approval for Ameluz in Basal Cell Carcinoma Sionna Advances SION-451 and SION-2222 Into Phase 2a Agomab Advances AGMB-447 Into Phase 2 for IPF Revolution Medicines Gains FDA Breakthrough Designation for RASONQUE J&J’s RYBREVANT Shows Longest OS in EGFR Lung Cancer AbelZeta’s C-CAR168 Receives FDA IND Clearance Curium Gains FDA Approval for BEXLUTRY in GEP-NETs TuHURA’s TBS-2025 Receives FDA IND Clearance for AML Clearmind Medicine Advances CMND-100 Into AUD Clinical Trial Quantum BioPharma Advances Lucid-MS Toward Phase 2 in MS Pharming Gains FDA Approval for Pediatric Joenja in APDS Amgen’s IMDELLTRA Gets Reduced FDA Monitoring Time Bausch + Lomb Gains CE Mark for SeeLyra Femtosecond Laser GSK’s Jideytro Shows 94% Response in ROS1 Lung Cancer Roche’s Tam-Peli Shows Survival Benefit in Relapsed SCLC Cyllene Therapeutics’ EG110A Gets FDA RMAT Designation Takeda Zasocitinib Gets FDA Priority Review for Psoriasis AstraZeneca and Daiichi Sankyo’s Enhertu Delivers 14.3-Month PFS in HER2-Mutant NSCLC GSK’s Ris-Rez Cuts Death Risk in Relapsed SCLC Eloxx Begins Phase 2b Study of Exaluren in Alport Syndrome AstraZeneca’s Tagrisso Delivers 8-Year Survival in Lung Cancer 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 CU Anschutz Wins FDA Clearance for CAR T Cancer Trial TwoStep Therapeutics Secures $62.5M and FDA IND Clearance 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