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.
Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its ...
Contract Pharma5d
FDA Approves Fapon Biopharma’s FP008 Cancer Therapy IND Application
The U.S. Food and Drug Administration (FDA) has approved Fapon Biopharma’s Investigational New Drug (IND) application for ...
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 ...
TMCnet5h
ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event
Event to include updates on ongoing evorpacept clinical development program and introduction of clinical trials in breast and colorectal cancers; Advancing novel EGFR-targeted ant ...
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, ...
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 ...