cGxP.wire https://validator.w3.org/feed/docs/rss2.html Abivax Reports Positive Phase 3 Obefazimod Maintenance Data Gain Therapeutics Wins FDA IND Clearance for GT-02287 Bioness Medical Secures FDA 510(k) Clearance for PoNS® AGC Biologics Partners with Pyramid for U.S. Fill-Finish Services Aspen Neuroscience Completes Cohort 4 in ASPIRO Parkinson’s Trial DBV Technologies Works With FDA to Finalize VIASKIN Peanut BLA Renalytix KidneyIntelX® Delivers Strong Two-Year DKD Outcomes Praxis Precision Medicines Extends FDA Review for Relutrigine NDA Arcutis Secures FDA Approval for ZORYVE in Children Aged 2+ ADC Therapeutics Advances ZYNLONTA® in LOTIS-7 Lymphoma Trial Genentech Wins FDA Priority Review for Enspryng in Thyroid Eye Disease BillionToOne Northstar Response® Advances Cancer Monitoring Inductive Bio Brings AI-Powered ADMET Models to Claude AbbVie Reports Positive Phase 3 Epcoritamab DLBCL Results FDA Selects Seven Firms for PreCheck Manufacturing Pilot DarioHealth and Beluga Partner to Transform Digital Chronic Care 4DMedical Unlocks Advanced CT:VQ Imaging for Australia Terumo Completes First U.S. OPUSWAVE Imaging Procedure Artivion Brings FDA-Approved AMDS to U.S. Heart Centers Zymeworks Acquires Theravance to Expand Healthcare Portfolio SetPoint Medical Delivers First FDA-Approved RA Device in N.C. Nuvation Bio Secures UK Review for Taletrectinib Daiichi Sankyo and AstraZeneca Secure EU Enhertu Approval REGENXBIO Doses First Patient in NAAVIGATE Gene Trial Talawar Therapeutics to Go Public in JATT II Merger Ipsen and Kartos Therapeutics Sign $1.75B Acquisition Deal Samsung Bioepis Reports Positive SB27 Keytruda Biosimilar Results Eisai Showcases Alzheimer’s Research at AAIC 2026 Meeting PharmaEssentia Secures FDA Approval for BESREMi Pen in Polycythemia Vera Nippon Shinyaku, Elixirgen Sign EXG-7001 DMD Option Deal OS Animal Health Shows Positive Phase 2 Results for OST-HER2 Acadia’s DAYBU Recommended for EU Approval in Rett Syndrome Capricor Reaches Key FDA Milestone in DMD Curis Reaffirms Initial Patient Dosing Timeline for TakeAim CLL Trial Epicrispr Advances Epigenetic Therapy With Promising FSHD Clinical Data Star Therapeutics to Present Phase 1/2 VGA039 Data at ISTH 2026 Siren Biotechnology Secures $8M CIRM Grant for SRN-101 Trial Organon Launches BILDYOS® and TUZEMTY® in Canada Monopar Therapeutics Presents Positive ALXN1840 Phase 3 Findings at EAN 2026 Viridian Wins FDA Approval for Lumvoa in Thyroid Eye Disease Arrowhead Wins EU Approval for REDEMPLO® in Rare Lipid Disease BridgeBio Reports Positive Phase 3 Oral Infigratinib Results for Achondroplasia Evaluate Wins AI Breakthrough Award for Ask Ella Platform Organon Completes Global MIUDELLA® Licensing Agreement Sanofi Wins Japan Approval for Wayrilz in Rare Blood Disease SK pharmteco Launches SKyvec™ Viral Vector Platform AstraZeneca, Daiichi Sankyo Advance Datroway Toward EU Approval Otsuka Reports Positive Phase 3b Results for Centanafadine Everest Medicines Eyes China Approval for LEROCHOL® PCSK9 Therapy Anivive Wins FDA Approval for First Oral Canine Lymphoma Drug