The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...
The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new drugs in clinical trials. The proposal aims ...
Outlook Therapeutics (OTLK Quick Quote OTLK - Free Report) reported preliminary top-line results from the 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 (Lytenava) to treat ...
ONS-5010 shows non-inferiority to Lucentis at 12 weeks; BLA resubmission planned for Q1 2025, with $20.4M in proceeds expected. ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, ...
Novartis' GanLum met the primary endpoint in the phase III KALUMA malaria study. GanLum achieved a 97.4% cure rate versus 94.0% for Coartem, meeting non-inferiority criteria. The therapy remained ...
Paris, France, 14-17 May 2024. The Course Directors have selected 3 major Late Breaking Trials (LBTs) that will be presented for the first time during the 2024 edition of EuroPCR. These trials were ...
New study findings show that utilizing super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent expansion ...
A randomized, double-blind, non-inferiority study was conducted to evaluate efficacy of bedinvetmab compared to grapiprant using objective force plate gait analysis (FPGA). Thirty-two eligible dogs (> ...
The study achieved the primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% and for ...
Novartis NVS reported positive top-line data from a late-stage study of its investigational new malaria treatment candidate, KLU156 (ganaplacide/lumefantrine, or ...
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