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Clinical & Diagnostic

OGT secures FDA De Novo classification for CytoCell® KMT2A FISH probe as companion diagnostic to Syndax’s Revuforj®

OGT, a leading global provider of genomic diagnostic and research solutions, announced that the U.S. Food and Drug Administration (FDA) has granted th...

September 23, 2025 | News

JCR Pharmaceuticals Achieves Milestone with Alexion in Neurodegenerative Disease Collaboration

-JCR Pharmaceuticals Co., Ltd., a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, has achieved ...

September 22, 2025 | News

Henlius and Organon Secure EC Approvals for Denosumab Biosimilars BILDYOS® and BILPREVDA®

Shanghai Henlius Biotech, Inc., and Organon announced the European Commission (EC) has granted marketing authorization for BILDYOS® (de...

September 22, 2025 | News

Kexing Biopharm Completes FDA Type II DMF Registration for Stem Cell-Derived Exosomes

Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Ma...

September 18, 2025 | News

Johnson & Johnson’s Amivantamab–Lazertinib Combo Extends Survival Beyond Four Years in Asia NSCLC Cohort

Median overall survival in Asia cohort is projected to exceed four years, demonstrating a durable benefit and surpassing osimertinib monotherapy by more th...

September 17, 2025 | News

Co-Diagnostics Signs Saudi MOU to Establish Joint Venture for PCR Manufacturing and Distribution in the Middle East

The Memorandum of Understanding includes the formation of a Joint Venture in the Kingdom of Saudi Arabia for manufacturing and distribution of th...

September 17, 2025 | News

Japan Approves Novocure’s Optune Lua for Concurrent Use with PD-1/PD-L1 Inhibitors in Advanced NSCLC

Optune Lua is now approved for use concurrently with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced/recurrent NSCLC who progressed on...

September 17, 2025 | News

Rona Therapeutics Submits RN3161 to Australian HREC as INHBE-Targeting GalNAc siRNA for Obesity

Rona Therapeutics, a global leader in developing next-generation RNAi therapeutics, announced the successful submission of RN3161 to the Australian Human R...

September 16, 2025 | News

Alphamab Oncology’s NDA for KN026 Accepted by NMPA for HER2-Positive Gastric Cancer

Alphamab Oncology announced that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed ...

September 15, 2025 | News

Kazia’s Paxalisib Disrupts Circulating Tumour Cell Clusters in HER2-Positive Metastatic Breast Cancer Study

Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced new findings from a collaborative research program...

September 12, 2025 | News

Lunit Secures Landmark Framework Agreement to Deploy Breast Imaging AI Across 1,500+ French Public Hospitals

Framework agreement with UniHA enables access to Lunit's breast AI solutions across 1,500+ French public hospitals, in collaboration with Fujifilm L...

September 12, 2025 | News

Telix Doses First Patient In Phase 3 BiPASS™ Trial Evaluating Illuccix® And Gozellix® For Prostate Cancer Diagnosis

Telix Pharmaceuticals Limited announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix&re...

September 11, 2025 | News

Contrast-Enhanced Ultrasound Shows Promise for Early Pancreatic Cancer Detection

A new study shows that contrast enhanced ultrasound (CEUS) techniques offer an encouraging option for noninvasively detecting pancreatic cancer in its earl...

September 11, 2025 | Report

Metabolon Partners with China Kadoorie Biobank to Advance Landmark Multiomics Study on Common Diseases

The landmark multiomics study will examine how lifestyle, environmental, socioeconomic, and genetic factors play a significant role in shaping common disea...

September 10, 2025 | News

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