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BioPharma Clinical Trials

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

Ascletis Completes Dosing in U.S. Trial of ASC47 and Semaglutide for Obesity

The combination study, conducted in the U.S., is designed to evaluate the safety, tolerability and preliminary efficacy at Day ...

July 15, 2025 | News

Amarna Therapeutics and NorthX Biologics Advance Nimvec™ AM510 Toward Clinical Trials for Type 1 Diabetes

Fast-Tracking Clinical Readiness: The agreement enables process and analytical development activities required to advance Nimvec™ AM510 for Type 1 ...

July 14, 2025 | News

Earendil Labs Completes First Cohort Dosing in Phase 1 Trial of Novel Anti-TL1A Antibody HXN-1001

Earendil Labs, an AI-empowered biotechnology company, announced that it has completed cohort 1 dosing in a phase 1 trial for a novel anti-TL1A antibo...

July 11, 2025 | News

Medidata Expands Partnership with NHMRC Clinical Trials Centre to Accelerate Innovation in Australian Clinical Research

Continuing collaboration will utilize the capabilities of the Medidata Data Experience, fostering efficiency, fast-tracking research breakthroughs, and rai...

July 10, 2025 | News

SCG Cell Therapy Secures China NMPA IND Approval for First Cell Therapy Targeting Chronic Hepatitis B

SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, announ...

July 08, 2025 | News

InnoCare Pharma Receives IND Approval in China for Novel B7-H3 Targeted ADC ICP-B794

InnoCare Pharma, a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced the approval of the Inves...

July 07, 2025 | News

Akeso Doses First Patient in Phase Ia Trial of AK146D1, the World’s First Bispecific ADC Targeting Trop2 and Nectin4

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") has announced the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a...

July 04, 2025 | News

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