As reported by Pharmaceutical Technology, Alkermes has announced that its investigational therapy alixorexton has received orphan drug designation from both US and European regulators, marking a significant regulatory milestone for…
As reported on PharmaBiz, AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for ravulizumab (Ultomiris) for the…
As reported on MedCity News, the U.S. Food and Drug Administration (FDA) has issued draft guidance encouraging the thoughtful use of Bayesian statistical approaches in clinical trials, marking a notable…
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