non-inferiority
GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025
GSK; Spero Therapeutics; tebipenem HBr; oral carbapenem; Phase 3 PIVOT-PO trial; complicated urinary tract infections (cUTIs); non-inferiority; IDWeek 2025; regulatory filing; FDA submission
Lilly’s Mounjaro Matches Cardiovascular Benefit of Trulicity in Landmark Trial, Paving Way for Expanded Approval
Mounjaro; tirzepatide; Eli Lilly; cardiovascular outcomes; type 2 diabetes; SURPASS-CVOT; Trulicity; dulaglutide; major adverse cardiovascular events (MACE-3); non-inferiority; A1C reduction; weight loss; mortality; FDA expansion
Merck’s Subcutaneous Keytruda Shows Non-Inferiority in Phase 3 Trial, Paving Way for Regulatory Discussions
Merck, Keytruda, subcutaneous, cancer immunotherapy, phase 3 trial, non-inferiority, regulatory submissions
Lilly’s Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Four Phase 3 Trials
Eli Lilly, efsitora alfa, once-weekly insulin, diabetes management, Phase 3 trials, non-inferiority, A1C reduction, insulin therapy.