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
The partnership will focus on creating capabilities for quickly and accurately processing vast amounts of clinical data
The discussion at the fourth session was centered on the fusion of academic rigor and industrial pragmatism as a key to pioneering solutions for sustainable and prosperous future
The integrated company delivers a broad portfolio of over 30,000 lab products across microscopy, histology, and other research areas
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