Novo Nordisk’s etavopivat granted FDA orphan designation in thalassemia
Novo Nordisk’s (NVO) etavopivat was granted FDA orphan designation for treatment of thalassemias, according to a post on the agency’s ...
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U.S. FDA unveils Chemical Contaminants Transparency Tool
The CCT Tool is an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action ...
Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s Disease
Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s ...