Caplin Point announces completion of unannounced USFDA inspection
The inspection was concluded with zero observations
The inspection was concluded with zero observations
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
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
Emraclidine, a potential best-in-class, next-generation antipsychotic, is in trials designed to be registration enabling for schizophrenia
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
BAV has revolutionized the animal vaccination industry with its ground-breaking delivery methods that prioritize quality, safety, and efficacy
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