FDA puts clinical hold on BioNTech’s malaria vaccine trial
The FDA has ordered BioNTech to immediately halt its Phase I/II trial of malaria vaccine candidate BNT165e, pending changes.
Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
Ivor Elrifi, CEO of Tiziana Life Sciences, expressed enthusiasm about this milestone, stating, "We are excited to initiate this important clinical study with the support of the ALS Association grant.
Tiziana Life Sciences ticks up on IND submission for mid-stage trial of its ALS treatment
Tiziana Life Sciences (NASDAQ:TLSA) rises after the company said it is planning the submission of its Investigational New ...
Pharm Exec4d
FDA Approves Investigational New Drug Application for Fapon Biopharma’s Novel Immunotherapy for Solid Tumors
FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.
Takeda-Protagonist Therapeutics Partnered Investigational Drug Hits Primary Goal In Late-Stage Study In Patients With Type Of Blood Cancer
Protagonist Therapeutics, Inc. (NASDAQ:PTGX) and Takeda Pharmaceutical Co Ltd (NYSE:TAK) released topline results for the ...
Healio12d
FDA clears investigational new drug application for Zabalafin Hydrogel
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...
Targeted Oncology5d
FDA Clears IND for Phase 1 Trial of ADCE-T02 in Solid Tumors
The FDA approved the investigational new drug application for a phase 1 trial of ADCE-T02 in advanced solid tumors.
Benzinga.com2d
Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial
The company plans to submit an Investigational New Drug application or foreign equivalent for APG279. The company says cash, cash equivalents, and marketable securities were $731.1 million as of ...
manilatimes4h
Lisata Therapeutics and GATC Health Consummate First Step in Strategic Collaboration to use AI to Derisk and Accelerate Drug Development
Strategic collaboration harnesses GATC's proprietary Artificial Intelligence-powered, validated Multiomics Advanced Technology™ platform to rapidly optimize and derisk drug discovery and development, ...