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.
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.
Tiziana Life Sciences Ltd.: Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
NEW YORK, March 04, 2025) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully hu ...
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 ...
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.
labiotech4h
Seven biotech companies keeping Taiwan dynamic in 2025
Discover 7 biotech companies in Taiwan, a rising regional player in precision medicine, immunotherapy, and drug development!
Pharmabiz9h
CDSCO launches online registration for CROs
Gireesh Babu, New Delhi Wednesday, March 5, 2025, 14:45 Hrs [IST] With the registration of clinical research organisations (CROs) to b ...
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, ...
manilatimes1d
Quoin Pharmaceuticals Files U.S. and International Patent Applications for Novel Topical Rapamycin Formulations to Treat Rare Disease Indications
Proprietary Invisicare Delivery Technology Designed to Optimize Local Skin Penetration The proprietary Invisicare delivery technology, which Quoin has exclusive rights to for all orphan rare skin ...
GlobalData on MSN5d
New EU trial regulations could expedite approvals and address shortages
New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials ...