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Clinical Trials

South Korea’s DXVX Inks $220M Global Out-Licensing Deal for mRNA Cancer Vaccine with U.S. Biotech

Dx&Vx (DXVX) has signed its first-ever global out-licensing agreement since its establishment. DXVX announced that it has entered into a co-developmen...

July 31, 2025 | News

Alphamab Oncology’s HER2-Targeting ADC JSKN003 Secures FDA Orphan Drug Designation for Gastric and GEJ Cancers

Alphamab Oncology announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Foo...

July 29, 2025 | News

Bristol Myers Squibb and Bain Capital Launch New Biotech Company with $300M to Advance Autoimmune Therapies

Five immunology assets in-licensed from BMS with potential to address unmet needs for patients with autoimmune diseases, including late-stage asset for...

July 29, 2025 | News

Suzhou’s Kintor Pharma Reports Positive Phase II Results for KX-826 in AGA Trial, Clears Path for Phase III

Kintor Pharmaceutical Limited (the "Company") is pleased to announce that the Phase II Stage of the Pivotal Clinical Trial of its in-house developed and po...

July 28, 2025 | News

GNT Pharma Receives South Korea’s Green Light to Launch Global Phase 3 Trials for Breakthrough Stroke Drug Nelonemdaz

GNT Pharma, a late-stage biopharmaceutical company with operations in Seoul and New York, announced its IND Application to commence Glo...

July 25, 2025 | News

Akeso Enrols First Patient in Phase III Trial of Ivonescimab for Metastatic Pancreatic Cancer

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase II...

July 24, 2025 | News

Hillhurst Doses First Patient in Phase 2a Trial of Oral CO Therapy for Sickle Cell Disease

Hillhurst Biopharmaceuticals Inc. ("Hillhurst"), a clinical-stage biopharmaceutical company focused on developing novel oral liquid drug products bas...

July 24, 2025 | News

BD Launches First Pharma-Sponsored Clinical Trial Using Libertas™ Wearable Injector for Subcutaneous Biologic Delivery

The selection of BD Libertas™ Wearable Injector for this pharma-sponsored trial follows successful outcomes from more than 50 BD-conducted pr...

July 24, 2025 | News

China’s DualityBio Secures FDA Fast Track for Next-Gen HER3 ADC DB-1310 in Advanced Lung Cancer

DualityBio announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting a...

July 23, 2025 | News

South Korea Approves Clinical Trial of DeepQure’s HyperQure™ System for Atrial Fibrillation

DeepQure announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a clinical trial of HyperQure™ RDM System, the c...

July 21, 2025 | News

FDA Pulls Emergency Brake on Sarepta's Gene Therapy Trials Amid Fatal Safety Crisis

The U.S. Food and Drug Administration announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dy...

July 21, 2025 | Regulatory

Senhwa Biosciences’ CX-5461 Selected by U.S. National Cancer Institute for Major Oncology Research Programme

Senhwa Biosciences, Inc., a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, ...

July 17, 2025 | News

Akeso Begins Phase III Trial of Ivonescimab for Hard-to-Treat Advanced Colorectal Cancer

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been successfully enrolled in the registration Phas...

July 16, 2025 | News

Taiwan’s Senhwa Biosciences’ CX-5461 Selected by U.S. National Cancer Institute for Major Oncology Research Programme

Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious d...

July 16, 2025 | News

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