cGxP.wire https://validator.w3.org/feed/docs/rss2.html Alkermes Publishes Alixorexton Phase 2 Narcolepsy Data Gilead Wins FDA Approval for Bixlenvo HIV Single Tablet Adicet Bio Gains FDA Clearance for ADI-212 IND in mCRPC Pfizer and BioNTech Win FDA Approval for XFG COVID-19 Vaccine Polaryx Advances SOTERIA Phase 2 Trial Readiness Zymeworks Wins FDA Approval for Ziihera in HER2+ GEA Tempus AI Wins FDA Clearance for ECG Pulmonary Hypertension Tool Spyre Reports SPY072 Rheumatoid Arthritis Phase 2 Results 4basebio and Genezen Expand Synthetic DNA Collaboration Nxera Pharma Earns $10M Milestone as Neurocrine Wins FDA Acceptance for Alzheimer’s Phase 2 Study Summit Therapeutics Reports Positive Phase III BTC Results HepaRegeniX: FDA Grants Orphan Drug Status to Darizmetinib Cellenkos Wins FDA Fast Track for CK0803 in ALS Harbour BioMed Advances Antibody Pipeline and AI Strategy IMUNON Highlights Phase 3 OVATION 3 Trial at R&D Day Caris Life Sciences Links AI to Longer Survival in Pancreatic Cancer NeoGenomics Gains Medicare Coverage for RaDaR ST Monitoring FibroBiologics Releases Third CYWC628 Batch for DFU Trial Natera and Angiex Partner to Track AGX101 Response Spineart Gains FDA Clearance for PERLA TL Robotic Use Daiichi Sankyo Begins Phase 1 Trial of CD25 ADC DS1025 ReviR Therapeutics Gains FDA Pediatric Designation for RTX-117 Slate Medicines Doses First Participant in SLTE-1009 Study Philips Wins $33.7M ARPA-H Award for Robotic Stroke Care Immuneering Advances Atebimetinib in Pancreatic Cancer Amgen and AstraZeneca Report Positive Phase 3 EoE Data Bridge to Life’s VitaSmart Gains UK NHS Funding Backing Biohaven, SK Biopharmaceuticals Sign Global Opakalim Deal AbbVie Submits SKYRIZI SC Induction Application to EMA Agenus Reports Deep Responses in Neoadjuvant Colon Cancer Autonomix Medical Expands U.S. Patent Protection for Neuromodulation Revolution Medicines Wins FDA Approval for RASONQUE™ in Metastatic Pancreatic Cancer HaemaLogiX Advances KMCAR™ T-Cell Clinical Program Daiichi Sankyo, AstraZeneca Advance Datroway in Phase 3 Urothelial Cancer Trial INmune Bio Advances Ebstrocel Toward EU Marketing Filing BridgeBio Starts Phase 3b/4 ASCEND-ATTR Acoramidis Study Eli Lilly Links Zepbound to Lower Healthcare Costs Kowa Pharmaceuticals America Advances K-911 FDA Review RenovoRx Highlights TAMP Targeted Drug Delivery Data Mend Expands Mend Well Into Chronic Care Management HCW Biologics Advances TGF-β/IL-15 Cancer Immunotherapy Vascarta Advances VAS-101 as Non-Opioid Pain Therapy SOTIO’s SOT106 ADC Gets FDA Fast Track for Sarcoma Mahzi Therapeutics Wins FDA Rare Pediatric Disease Designation Jazz Pharmaceuticals Gains FDA Approval for HER2+ GEA Masimo Gains FDA Clearance for Continuous Oxygen Delivery Monitoring Abbott Gains FDA Authorization for Dual Glucose-Ketone Sensor BeOne Wins FDA Approval for TEVIMBRA HER2+ GEA Regimen Celcuity Files FDA sNDA for REVTORPYK in Breast Cancer Osivax, GC Biopharma Partner on Next-Gen Flu Vaccine