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
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
Alvotech Launches Europe’s First Biosimilar to Simponi® With Gobivaz® Rollout

Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, a...

December 24, 2025 | Wednesday | News
Symbiosis Manufactures First 10,000-Vial Batch at New Stirling Sterile Fill-Finish Facility

Symbiosis Pharmaceutical Services (Symbiosis), a leading sterile fill finish contract manufacturing organisation (CMO), has manufactured their first 10,0...

December 24, 2025 | Wednesday | News
Mondego Bio Selects Lead PTPN2 Inhibitor ZE00-0388, Enters Clinical Stage

Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, announced the formal selection o...

December 23, 2025 | Tuesday | News
Daiichi Sankyo–AstraZeneca’s DATROWAY Clears EMA Validation, Advancing Toward First-Line Use in Metastatic TNBC

Based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s DATROWAY is the first and only medicine to significantly...

December 19, 2025 | Friday | News
Symeres Secures SBTi Approval for Science-Based Emissions Reduction Targets

Symeres, a leading contract research, development, and manufacturing organisation (CRDMO), has received its first approval from the Science Based Targets i...

December 19, 2025 | Friday | News
Norgine Secures Exclusive Rights to Vir Biotechnology’s Hepatitis Delta Combination Therapy

Agreement underscores Norgine's mission to bring innovative therapies to patients and builds on our heritage in hepatology and specialty pharmaceutical...

December 18, 2025 | Thursday | News
Affibody Advances HER2 Radioligand Therapy ABY-271 to Next Phase of Clinical Study

Affibody AB announced that the Trial Review Committee (TRC) has recommended to advance the Phase I clinical study with the Radioligand Therapy (RLT) cand...

December 17, 2025 | Wednesday | News
Greenwich LifeSciences Reports ~80% Reduction in Breast Cancer Recurrence in Phase III FLAMINGO-01 Non-HLA-A*02 Arm

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO...

December 16, 2025 | Tuesday | News
Sobi Acquires Arthrosi for Up to USD 1.5 Billion, Securing Phase 3 Pozdeutinurad for Progressive Gout

Expands Sobi's pipeline with a highly differentiated new Phase 3 asset in Gout Acquisition expected to be highly accretive to...

December 15, 2025 | Monday | News
Savara Secures Key European Patent for MOLBREEVI as It Prepares Global Regulatory Filings

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...

December 12, 2025 | Friday | News

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