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
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
Bristol Myers Squibb to Provide Eliquis Free to U.S. Medicaid, Expanding Access to the Nation’s Most Prescribed Blood Thinner

Eliquis® (apixaban), the Nation’s #1 Prescribed Oral Blood Thinner, Soon Available for Free to Medicaid Program Agreement Provides Tariff Re...

December 22, 2025 | Monday | News
Parse Biosciences Partners With Codebreaker Labs to Crack Rare Variant Mapping at Single-Cell Scale

Collaboration pairs robust synthetic biology platform with massive scale single cell sequencing to overcome long-standing challenges in variant mapping...

December 22, 2025 | Monday | 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
Takeda’s Zasocitinib Delivers Strong Phase 3 Wins in Plaque Psoriasis

Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe plaque psor...

December 19, 2025 | Friday | News
Antengene Expands XPOVIO® Approval in Malaysia to Relapsed or Refractory DLBCL

Antengene Corporation Limited, a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing fir...

December 18, 2025 | Thursday | News

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