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
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
AusperBio Completes Phase III AUSHINE Trial Enrollment for Chronic Hepatitis B Therapy AHB-137

 AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio), a clinical-stage biotechnology company developing targeted oligon...

December 23, 2025 | Tuesday | News
FNIH Secures FDA Qualification of Hip Bone Mineral Density as Surrogate Endpoint in Osteoporosis Trials

Measuring change in bone mineral density, rather than fracture occurrence, promises to speed development of new drugs to treat osteoporosis. FNIH Bi...

December 22, 2025 | Monday | 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
Inhibrx Advances INBRX-106 and Ozekibart Programs, Expands Clinical Momentum Across Solid Tumors

Inhibrx Biosciences, Inc. a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology announced an update on the INBR...

December 18, 2025 | Thursday | News

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