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 Exec5d
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.
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.
BioNTech stock falls after FDA clinical hold on malaria vaccine trial
The FDA’s clinical hold has prompted a cautious response from investors, reflecting the heightened regulatory scrutiny that BioNTech now faces. The company’s immediate focus will be on resolving 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 ...
manilatimes5h
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, ...
Allogene Therapeutics: Disrupting CAR-T With A Scalable Model
Allogene Therapeutics is undervalued. Read more on ALLO stock's cash runway, innovative CAR-T therapies, and market expansion ...
GlobalData on MSN9d
DeFloria launches Phase II ASD irritability cannabis therapy trial
The Phase II trial comes as the US Food and Drug Administration grants an investigational new drug application for cannabis ...