Drug Development
Page 1 • 12 itemsGain critical insights into global drug development trends, clinical trial advancements, regulatory hurdles, and R&D strategies for pharma investors and BD.
InflaRx Izicopan Shows Low Reactive Metabolite Formation in Liver Safety Study
InflaRx reports favorable safety data for Izicopan showing low reactive metabolite formation in human liver microsomes, reducing bioactivation risks.
InflaRx Reports Favorable Safety Profile for Izicopan in Liver Metabolism Study
InflaRx announces positive pre-clinical data showing low reactive metabolite formation for izicopan in human liver microsomes, supporting drug safety profile.
Addex Advances Dipraglurant for Brain Injury Recovery, Reports 2025 Financial Results
Addex repositions dipraglurant mGlu5 NAM for brain injury recovery while advancing GABAB PAM chronic cough candidate toward clinical trials in 2025 update.
Viking Therapeutics VK2735 Phase 3 Obesity Trials Fully Enrolled as Company Reports Q1 2026 Results
Viking Therapeutics advances VK2735 obesity treatment with fully enrolled Phase 3 trials and $603M cash position, oral formulation trial expected Q4 2026.
Sprout Pharmaceuticals Addyi (Flibanserin) Maker Named Top 10 Most Influential Health Company by TIME 2026
Sprout Pharmaceuticals, maker of Addyi (flibanserin), joins TIME's 10 most influential health companies of 2026 following FDA approval expansion and growth.
FDA Proposes OMUFA User Fee Program for Over-the-Counter Monograph Drugs to Supplement Congressional Funding
FDA introduces OMUFA user fee program for OTC monograph drugs as potential funding mechanism to supplement congressional appropriations for regulatory oversight.
FDA Achieves Year 1 Goals in Reducing Animal Testing for Drug Development Through Alternative Methods
FDA successfully launches key initiatives to replace animal testing with alternative methods in drug development, achieving first-year roadmap goals.
Avacta's AVA6103 Cancer Drug Shows Superior Profile vs Enhertu in AACR 2026 Data
Avacta presents promising AVA6103 data at AACR 2026, showing robust activity in low FAP expression tumors and favorable kinetics vs marketed ADC Enhertu.
Aquestive Therapeutics Faces FDA Deficiencies for Anaphylm Drug Application, Class Action Lawsuit Filed
FDA identifies deficiencies in Aquestive's Anaphylm NDA, blocking approval discussions. Class action lawsuit alleges misleading investor communications.
Mabwell's Nectin-4 ADC Bulumtatug Fuvedotin Shows Promise in Cervical Cancer Case Report Published in NEJM
Mabwell's novel Nectin-4 targeting ADC bulumtatug fuvedotin (9MW2821) demonstrates clinical potential in cervical cancer treatment, according to NEJM case report.
Adcendo ApS Advances ADCE-T02 Antibody-Drug Conjugate to Expansion Phase, ADCE-D01 Receives FDA Orphan Drug Status
Adcendo ApS reports pipeline progress with ADCE-T02 entering cohort expansion in solid tumors and ADCE-D01 receiving FDA Orphan Drug Designation for cancer treatment.
Whitehawk Therapeutics HWK-007 Shows Promise in AACR 2026 ADC Data Presentation
Whitehawk Therapeutics presents preclinical data for HWK-007, HWK-016, and HWK-206 ADCs at AACR 2026, with Phase 1 trials ongoing for lead candidates.