Qihan Biotech Receives FDA Clearance to Begin U.S. Trial of Universal CAR-T Therapy for Refractory Lupus

Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to...

August 19, 2025 | Tuesday | News
European Commission Approves OGSIVEO® as First-Ever Therapy for Desmoid Tumours

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced that the European Commission (EC) granted marketing aut...

August 19, 2025 | Tuesday | Regulatory
Ryght AI and Biorasi Partner to Transform Clinical Trial Feasibility with AI Digital Twins

Ryght AI, the clinical trials AI technology company transforming site activation and optimization through AI digital twins of every research site in the ...

August 18, 2025 | Monday | News
Sanofi Advances Rare Disease Pipeline as Rilzabrutinib Gains EMA Orphan Status in IgG4-RD

Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at EULAR 2025 Additional orphan desi...

August 18, 2025 | Monday | News
Regen BioPharma Advances HemaXellerate Toward Phase 1 Trials Following FDA Clearance

Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company&...

August 18, 2025 | Monday | News
Ascentage Pharma Receives FDA and EMA Clearance for Global Phase III Trial of Lisaftoclax in Higher-Risk MDS

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and c...

August 18, 2025 | Monday | News
Jabez Biosciences Expands Phase 1 Trial of JBZ-001 with Second Clinical Site

Jabez Biosciences, Inc., a clinical-stage biopharmaceutical company dedicated to ushering in the future of cancer therapy with their seamless, scalable a...

August 18, 2025 | Monday | News
Invivyd Secures FDA Alignment on Single Phase 2/3 Trial Pathway for VYD2311 COVID-19 Prevention BLA

Alignment follows Type C meeting for VYD2311 as previously disclosed BLA pathway for VYD2311 to be supported by a single, Phase 2/3 randomized, doubl...

August 15, 2025 | Friday | News
Simpson Interventions Treats First Patients in Pivotal Trial of Acolyte™ Image-Guided Catheter for Complex Coronary Blockages

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, announced that its groundbrea...

August 15, 2025 | Friday | News
Massive Bio and Prognos Health Forge Exclusive Partnership to Advance AI-Enabled Oncology Trial Matching

-Massive Bio, a leader in AI-enabled oncology trial matching and patient access, and Prognos Health, a provider of actionable lab data,  announced a...

August 13, 2025 | Wednesday | News
China’s Kexing Biopharm Forms Strategic Alliance with IQVIA to Accelerate Global Drug Development and Commercialisation

 Kexing Biopharm (688136.SH) has officially entered into a comprehensive strategic partnership with IQVIA(NYSE:IQV), a global leader in clinica...

August 12, 2025 | Tuesday | News
Akeso Doses First Patient in Phase III Trial of Ivonescimab for Limited-Stage Small Cell Lung Cancer

Akeso, Inc.announced that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating...

August 11, 2025 | Monday | News
Junshi Biosciences’ sNDA for Toripalimab Plus Disitamab Vedotin in HER2-Expressing Urothelial Carcinoma Accepted by China’s NMPA

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to th...

August 11, 2025 | Monday | News
Boehringer Ingelheim Secures FDA Accelerated Approval for HERNEXEOS® (Zongertinib) in HER2-Mutant Advanced NSCLC

HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial ...

August 11, 2025 | Monday | News

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