cGxP.wire https://validator.w3.org/feed/docs/rss2.html BeOne Medicines Gains FDA Priority Review for TEVIMBRA Kernal Biologics Showcases mRNA 2.0 CAR-T Platform Neurocrine Defines TDIS Threshold for TD Treatment Impact Iterative Health Secures $77M to Accelerate Clinical Trials Huahui Health, BeOne Strike $2B HH160 Oncology Deal Made Scientific Expands Board for Cell Therapy Scale-Up OS Therapies Secures EMA Review for OST-HER2 Drug Theradaptive Gains FDA Approval for Regenerative Spine Therapy AC Immune Advances ACI-24 Alzheimer’s Trial Expansion Century Therapeutics Highlights CNTY-813 Data at ADA Immunome Files FDA NDA for Varegacestat in Tumors Renibus Reports Phase 3 RBT-1 Data at AATS Meeting Cocrystal Pharma Advances CDI-988 for Norovirus Care EnGeneIC Doses First Patient in GBM EDV Therapy Trial Chiesi to Acquire KalVista in $1.9B Rare Disease Deal Axsome Therapeutics Secures FDA Approval for AUVELITY in Alzheimer’s Agitation IDEAYA Advances NDA for Darovasertib Under FDA RTOR Novo Nordisk Reports Strong Phase 3 Results for Denecimig in Hemophilia A Laguna Gains FDA IND Clearance for LGNA-100 Therapy Thermo Fisher Opens US Bioprocess Center to Boost Biologics SetPoint Medical Starts MS Study for Neuroimmune Therapy TRexBio Advances TRB-061 Phase 1b Trial for Atopic Dermatitis BRC Therapeutics Secures FDA IND Clearance for BRC-002 Therapy BioLineRx & Hemispherian Dose First Patient in GLIX1 GBM Trial Pharmascience Launches pms-DOLUTEGRAVIR in Canada Aidoc Secures $150M Led by Goldman Sachs for AI Growth Earflo Wins FDA Clearance for Pediatric Ear Device Telix Advances TLX597-Tx Phase 2 Prostate Cancer Program Olympus Gains FDA Clearance for POWERSEAL Open Device Profluent, Lilly Partner to Advance AI Gene Editing Tech PreludeDx Secures FDA Breakthrough for AidaBREAST Test Mesoblast Completes Enrollment in Pivotal Phase 3 Trial for Chronic Low Back Pain Kestrel Therapeutics Doses First Patient in KRAS Trial AcuraStem Secures $7.5M to Advance AS-241 for ALS and FTD CareDx Acquires Naveris to Expand Precision Oncology InnoCare Advances Phase III Orelabrutinib Trial for SLE EnteroBiotix Secures £19M for Phase 2b IBS-C Trial Vanda Pharma Publishes Phase III Imsidolimab Data HUTCHMED Advances Sovleplenib NDA for wAIHA in China Teva Pharmaceutical Acquires Emalex to Advance Tourette Therapy Henlius and Organon Secure EU Approval for POHERDY® Latus Bio Advances Gene Therapy Programs for Rare CNS Diseases Affinia Therapeutics Advances AFTX-201 for BAG3 DCM AVITA Medical Secures TGA Approval for RECELL GO in Australia Orca Bio Secures FDA RMAT Status for Orca-Q Therapy AstraZeneca Breztri Becomes First Triple Therapy Approved for Asthma in US Paradigm Health, FDA Advance Real-Time Trial Review Model GSK Bepirovirsen Wins FDA Priority Review Breakthrough Status Avenzo Therapeutics Advances Dual CDK Inhibitor Breast Cancer Study Bambusa Therapeutics Completes BBT001 Trial Enrollment