cGxP.wire https://validator.w3.org/feed/docs/rss2.html 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 Ipsen and Kartos Therapeutics Sign $1.75B Acquisition Deal Samsung Bioepis Reports Positive SB27 Keytruda Biosimilar Results 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 Eisai Showcases Alzheimer’s Research at AAIC 2026 Meeting Talawar Therapeutics to Go Public in JATT II Merger REGENXBIO Doses First Patient in NAAVIGATE Gene Trial NeuroSense PrimeC Shows Positive Phase 2 Alzheimer’s Biomarker Data 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 Novo Nordisk Showcases New Hemophilia Data Featuring Denecimig at ISTH 2026 Curis Reaffirms Initial Patient Dosing Timeline for TakeAim CLL Trial Lilly Jaypirca CHMP Backs EU Approval for CLL Treatment Epicrispr Advances Epigenetic Therapy With Promising FSHD Clinical Data Siren Biotechnology Secures $8M CIRM Grant for SRN-101 Trial Arrowhead Wins EU Approval for REDEMPLO® in Rare Lipid Disease Viridian Wins FDA Approval for Lumvoa in Thyroid Eye 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 LENZ Therapeutics Partners Arrotex to Launch VIZZ in ANZ Merck KGaA to Acquire Bio-Techne in $11.3B Life Science Deal Chiesi, Arbor Secure EU Orphan Status for ABO-101 Ionis Partners with Recordati to Expand Zilganersen Globally Anivive Wins FDA Approval for First Oral Canine Lymphoma Drug Anixa Biosciences Reports Positive Phase 1 Cancer Vaccine Data Johnson & Johnson Highlights New IMAAVY Data at EAN 2026 Star Therapeutics to Present Phase 1/2 VGA039 Data at ISTH 2026 Sobi Receives FDA Complete Response Letter for NASP BLA Aidoc Receives FDA Breakthrough Device Designation for First Read AI Organon Launches BILDYOS® and TUZEMTY® in Canada Lupin Receives U.S. FDA Tentative Approval for Enzalutamide Tablets AbbVie Secures FDA Approval for SKYRIZI in Pediatric Psoriatic Disease Monopar Therapeutics Presents Positive ALXN1840 Phase 3 Findings at EAN 2026