News | August 07, 2024
Sucralose safe to use in small doses; reveals MDRF study
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
Integrated Disease Surveillance Programme (IDSP) strengthened to improve disease surveillance and rapid data reporting
Report highlights significant improvements in adolescent well-being in India
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
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