cGxP.wire https://validator.w3.org/feed/docs/rss2.html Calico Wins FDA Breakthrough Status for Fosigotifator NeuroSense PrimeC Shows Positive Phase 2 Alzheimer’s Biomarker Data Lilly Jaypirca CHMP Backs EU Approval for CLL Treatment Ionis Wins FDA Approval for TRYNGOLZA in Severe Hypertriglyceridemia Novo Nordisk Showcases New Hemophilia Data Featuring Denecimig at ISTH 2026 Anixa Biosciences Reports Positive Phase 1 Cancer Vaccine Data Johnson & Johnson Highlights New IMAAVY Data at EAN 2026 Revolution Medicines Presents RAS(ON) Data at ESMO 2026 Sobi Receives FDA Complete Response Letter for NASP BLA Aidoc Receives FDA Breakthrough Device Designation for First Read AI Lupin Receives U.S. FDA Tentative Approval for Enzalutamide Tablets AbbVie Secures FDA Approval for SKYRIZI in Pediatric Psoriatic Disease C Ray Therapeutics Secures Key Radiopharmaceutical License Taysha Gene Therapies Showcases TSHA-102 Progress at 2026 IRSF Meeting Castle Biosciences Reports DecisionDx-Melanoma Improves SLNB Risk Prediction Cantargia Publishes Data Validating IL1RAP as a Key PDAC Target MaaT Pharma to Seek EMA Re-Examination for Xervyteg After CHMP Rejection AIM ImmunoTech Advances Ampligen Toward Potential Pivotal Development CalciMedica Receives FDA Clearance to Continue Auxora KOURAGE Trial Calidi Showcases RedTail Platform at T-Cell Engager Therapeutic Summit Cadrenal Highlights Phase 2 CAD-1005 Trial in Prestigious ISTH 2026 Session Verici Dx Achieves Nationwide Access Following New York State Approval IIMU Biosciences and Waters Advance AI-Driven Immune Mapping Technology Wave Life Sciences Initiates Phase 2a INLIGHT™ Trial of WVE-007 for Obesity and Cardiometabolic Diseases Lilly Completes Centessa Deal to Accelerate Treatments for Narcolepsy and Sleep-Wake Disorders REPROCELL Files Japan Approval Application for Stemchymal® Children’s Hospital of Philadelphia Advances Targeted Cancer Immunotherapy Research AL-S Pharma Reports Positive Phase 2 AP-101 Data at ENCALS 2026 Gilead Sciences Wins FDA Approval for Trodelvy in First-Line mTNBC CalciMedica Secures $49M Financing to Advance PH Program Viking Therapeutics Launches Phase 1 Study of VK3019 for Weight Loss Quest Diagnostics Secures New York Approval for Haystack MRD Cancer Test Knoa Pharma and GCAR Expand Glioblastoma Trial Efforts Pfizer Expands IBRANCE Label with New FDA Approval for HER2+ Breast Cancer CeleCor Submits FDA NDA for Zalunfiban After Phase 3 Success Sera Applauds Illinois Medicaid Coverage for PreTRM Blood Test Mabwell Receives China IND Clearance for 6MW5311 Cancer Therapy Abbisko Therapeutics and Lilly Expand Global R&D Partnership Cognivia and Mayo Clinic Partner to Improve Clinical Research Outcomes Allergan Aesthetics Wins Canada Approval for Boey Neurotoxin AbbVie Secures EU Approval for MAVIRET in Acute Hepatitis C Bridge to Life Showcases VitaSmart HOPE Data at ATC 2026 Ascletis Receives FDA IND Clearance for ASC35 Obesity Trial CereVasc Completes Pivotal STRIDE Trial Enrollment for eShunt Armata Secures $2.5M DoD Funding for AP-SA02 Mediar Starts Phase 1 Trial of MTX-439 in CKD HUTCHMED Reports Strong Phase II Fanregratinib Data in ICC Leal Therapeutics Doses First ALS Patient with LTX-002 Ollin Biosciences Announces $330M Series B to Accelerate OLN324 for DME and Wet AMD AnaCardio Publishes AC01 Heart Failure Study in The Lancet