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
Decision on EU marketing authorisation for this population expected by September 2024
Report highlights significant improvements in adolescent well-being in India
Access to breast milk for sick newborns admitted in intensive care units plays a lifesaving role
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis
The inspection was concluded with two 483 observations
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
The innovative ‘Street Safe’ Rapid Testing Kit should be provided to all vendors attending the Food Safety and Certification (FoSTaC) trainings to ensure that safe food is used by the street food vendors across the country
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