Mineralys to Present Lorundrostat Phase 3 Data at ASN Kidney Week 2026
Mineralys presents Lorundrostat Phase 3 results from the Launch-HTN trial at ASN Kidney Week 2026, testing efficacy in treatment-resistant...
Teva Presents Post Hoc Ecopipam Data Ahead of 2027 FDA Decision
Teva presents post hoc ecopipam data for pediatric Tourette syndrome ahead of the FDA's Q1 2027 decision, identifying patient...
FDA extends denecimig review timeline, no decision date set
FDA extends denecimig review with no target decision date set. Novo Nordisk's haemophilia A therapy remains under evaluation beyond...
Three regulatory guidelines converge on risk-based quality management for clinical trials
ICH E6(R3), E8(R1), and MHRA guidance now align on risk-based quality management for clinical trials, requiring sponsors to update...
FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors
FDA's AI Risk-Based Guidance shifts validation burden to sponsors, requiring documented credibility assessments before deploying AI in clinical trials.
Lundbeck presents MSA trial baseline data, Lu AF28996 Phase Ib results at MDS 2026
Lundbeck presents baseline enrollment data from Phase III MASCOT trial of amlenetug for multiple system atrophy, with efficacy results...
Nektar Discloses Phase 2b Data for REZPEG in Severe Alopecia Areata
Nektar disclosed Phase 2b data for REZPEG in severe alopecia areata, testing a regulatory T-cell stimulation approach against existing...
Monte Rosa’s MRT-8102 shows NLRP3 inflammasome activity normalization in Phase 1 study
Monte Rosa's MRT-8102 shows NLRP3 inflammasome activity normalization in Phase 1 study of 108 obese participants with elevated cardiovascular...
Survodutide delivers 13.1% weight loss in Phase III trial for obesity and type 2 diabetes
Survodutide delivers 13.1% weight loss in Phase III trial for obesity and type 2 diabetes, with significant glycemic improvements...
Clinical Trials Struggle to Recruit Undiagnosed Patients Without Diagnostic Coverage
Clinical trials recruit faces barriers when patients lack diagnoses. Diagnostic coverage gaps exclude 25M Americans from research participation.