Transcenta Therapeutics Enters Strategic Bioprocessing Collaboration With EirGenix

  Transcenta Holding Limited (HKEX: 06628) (“Transcenta Therapeutics”), a global clinical stage biopharmaceutical company with fully-inte...

December 31, 2025 | Wednesday | News
HUTCHMED’s Fanregratinib NDA for Intrahepatic Cholangiocarcinoma Accepted for Priority Review in China

NDA supported by results from a Phase II registration trial in China — — Second most common form of liver cancer after hepatocellular ...

December 31, 2025 | Wednesday | News
Harbour BioMed Forms Strategic Alliance With Lannacheng to Advance Next-Generation Radionuclide Drug Conjugates

Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immuno...

December 30, 2025 | Tuesday | News
Senhwa Biosciences Advances CX-5461 Into ADC Combinations With Enhertu® in NCI-Backed Phase 1b Trial

Following its recent clinical collaboration with the multinational pharmaceutical company BeOne Medicines to explore combination therapy with its markete...

December 30, 2025 | Tuesday | News
Viva Biotech Showcases Integrated PK/PD Platform Across Small Molecules, Peptides, PROTACs, and Antibodies

Drug Pharmacokinetics and Pharmacodynamics (PKPD) has become increasingly critical as drug discovery modalities continue to expand across a broader and m...

December 30, 2025 | Tuesday | News
Diamyd Medical Aligns with FDA to Accelerate Phase 3 DIAGNODE-3 Efficacy Readout in Type 1 Diabetes

Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, ...

December 30, 2025 | Tuesday | News
Hansa Biopharma Submits FDA BLA for Imlifidase in Highly Sensitized Kidney Transplant Patients

The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients Imlifida...

December 29, 2025 | Monday | News
FDA Approves Omeros’ YARTEMLEA® as the First and Only Treatment for Transplant-Associated Thrombotic Microangiopathy

First and only approved option: YARTEMLEA® is the only approved treatment for hematopoietic stem cell transplant-associated thrombotic microangio...

December 26, 2025 | Friday | News
Caliway Submits FDA IND for Phase 2 Study of CBL-514 in Combination With Eli Lilly’s Zepbound® for Weight Management

Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical...

December 26, 2025 | Friday | News
Flagship Pioneering and Pfizer Launch New Repertoire-Led Program to Develop TCR Bispecifics for Metastatic Prostate Cancer

Flagship Pioneering, a scientific innovation engine for transformative platforms and products, announced a research program under its strategic collabora...

December 25, 2025 | Thursday | News
datma and Rhythm Biosciences Launch Exploratory Collaboration to Advance Genomic-Integrated Cancer Risk Prediction

The two companies will explore how datma's federated ecosystem can support Rhythm Biosciences' diagnostic development efforts as they shape a future comm...

December 25, 2025 | Thursday | News
SN Bioscience’s SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer

SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (including gast...

December 25, 2025 | Thursday | News
Nona Biosciences Expands Integrated Discovery-to-Clinic Framework to Support Early Clinical Development and IITs

Nona Biosciences, a global biotechnology company advancing biotherapeutic discovery through innovative technology platforms, announced the expansion...

December 25, 2025 | Thursday | News
Orchestrating Scale In Cell And Gene Therapy From Trial Complexity To Commercial Reality

As cell and gene therapies move rapidly from pioneering clinical trials into commercial healthcare systems the industry is facing a defining inflection poi...

December 25, 2025 | Thursday | Interaction

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