cGxP.wire https://validator.w3.org/feed/docs/rss2.html Arcutis Secures FDA Approval for ZORYVE in Children Aged 2+ Telum Therapeutics Raises €18M Series A for AMR Program Aspen Neuroscience Completes Cohort 4 in ASPIRO Parkinson’s Trial Arcus Biosciences Publishes Casdatifan Kidney Cancer Data Neurocrine Initiates Phase 2 Trial of Crinecerfont in Children Under 4 with Classic CAH Renalytix KidneyIntelX® Delivers Strong Two-Year DKD Outcomes Vertex Secures FDA Approval to Expand CASGEVY Use in Young Children Envoy Medical Submits First Module of FDA PMA Application for Breakthrough Hearing Implant Advita Ortho Launches Next-Generation Knee Platform in Japan Francis Medical Publishes VAPOR 2 Trial Results in The Journal of Urology Headlands Research Expands California Footprint with Clinical Trials Research Acquisition Sanofi Nexviazyme Delivers Positive Phase 3 Pompe Trial Results BeOne Announces Positive Phase 3 Results for BRUKINSA RefleXion Submits FDA 510(k) for Anchor Point Tracking Laplace Gains FDA IDE for TRIUMPH TTVR Pivotal Trial Serenity Medical Receives FDA Breakthrough Device Designation for Shepherd Stent™ System Zambon Hopledo® Wins CHMP Backing for Parkinson’s Disease Cumulus Advances Alzheimer’s Research with NeuLogiq Platform Apotex Secures Health Canada Approval for SEVMIA™ STARMED Becomes First to Gain FDA Clearance for Thyroid RFA Contineum Therapeutics Publishes PIPE-791 Discovery Study Orca Bio Wins FDA Approval for TREGZI Cell Therapy Anixa Wins First Korean Patent for Breast Cancer Vaccine DBV Technologies Works With FDA to Finalize VIASKIN Peanut BLA Kowa Gains FDA Breakthrough Status for K-808 in PBC Saluda Medical Wins FDA Approval for CAP24 Paddle Lead Ipsen Acquires Memo Therapeutics to Expand Rare Disease Pipeline Samsung Bioepis Relaunches BYOOVIZ with Harrow in the U.S. Allucent Launches IGNITE™ to Accelerate Clinical Trials Palisade Bio Receives FDA IND Clearance for PALI-2108 Biodexa Expands Phase 3 Serenta Trial into Canada for FAP Pfizer Canada Secures PADCEV Plus KEYTRUDA Approval Roche Enspryng Gains FDA Priority Review for TED Treatment AbbVie RINVOQ® Moves Closer to EU Approval for Alopecia Areata CraniUS Secures NIH Grant for Glioblastoma Therapy Orion Pharma Expands Europe Biosimilar Portfolio with Shilpa Aurenar Wins FDA Breakthrough Device Status for V-Link™ Silo Pharma Advances SPC-15 PTSD Program Toward FDA Meeting Genmab Phase 3 Epcoritamab Trial Meets Primary PFS Endpoint Abivax Reports Positive Phase 3 Obefazimod Maintenance Data Bioness Medical Secures FDA 510(k) Clearance for PoNS® AGC Biologics Partners with Pyramid for U.S. Fill-Finish Services FDA Approves Tregzi to Prevent Chronic GVHD in Blood Cancer Gain Therapeutics Wins FDA IND Clearance for GT-02287 NIH Develops Blood Test to Predict Alzheimer’s Disease Progression Apnimed Appoints Industry Veterans to Drive AD109 Growth Praxis Precision Medicines Extends FDA Review for Relutrigine NDA 92Bio Doses First Patient in Phase 1 Trial of NTB-928 for Platinum-Resistant Ovarian Cancer Kyowa Kirin Reports Long-Term Survival Gains With Mogamulizumab Novocure Receives CE Mark for Optune Pax in Pancreatic Cancer