The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
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
Experienced commercial leader takes helm to expand cardiovascular diagnostic company globally and commercialize company’s flagship plaque analysis software
Finance Minister Nirmala Sitharaman is set to present the full budget for the current financial year on July 23
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Acquisition strengthens and diversifies Merck’s pipeline with the addition of Restoret
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
Dyslipidemia is a critical risk factor for cardiovascular diseases
GL0034 administered once-weekly confirmed clinically meaningful weight loss and improved glucometabolic parameters over a 4-week treatment period in individuals with obesity
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