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
Mereo BioPharma’s Phase 3 Setrusumab Studies Miss Primary Fracture Endpoints in Osteogenesis Imperfecta

Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates (COSMIC) Bo...

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
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
T-MAXIMUM Pharmaceutical Secures FDA IND Clearance for Allogeneic CAR-T MT027 in Recurrent Glioblastoma

T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food an...

December 29, 2025 | Monday | News
Promontory Therapeutics Exceeds Interim Efficacy Bar in Phase 2 Thymoma Study of PT-112

Three of the first 10 patients with thymoma evaluated by RECIST have partial responses. Findings exceed protocol requirement of two...

December 29, 2025 | Monday | News
Foresee Pharmaceuticals’ FP-001 Meets Phase 3 Primary Endpoint in Central Precocious Puberty

The proportion of patients with serum luteinizing hormone (LH) suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimula...

December 29, 2025 | Monday | News
Biohaven Reports Phase 2 Results for BHV-7000 in Major Depressive Disorder

Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization o...

December 26, 2025 | Friday | News
Innovent’s TABOSUN® Plus TYVYT® Becomes World’s First Approved Dual-IO Neoadjuvant Therapy for MSI-H/dMMR Colon Cancer in China

TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant...

December 26, 2025 | Friday | 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
Hope Biosciences Reports Phase II Breakthrough Showing Significant Motor Improvement in Parkinson’s Disease

Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF)  shares positive top-line results of a Phase II clinical tri...

December 24, 2025 | Wednesday | News
Biosplice Doses First Patient in Phase 1 Trial of Cirtuvivint Plus Olaparib for Resistant Ovarian Cancer

Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company advancing small-molecule inhibition of CDC-like kinases (C...

December 24, 2025 | Wednesday | News

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
Processing...
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2026 Biopharma Boardroom. All Rights Reserved.

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close