US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA
Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
BioMarin’s Voxzogo, J&J’s cilta-cel and Takeda’s maribavir are among the novel agents with goal dates on US FDA’s November user fee calendar.
No drugs are approved for epidermolysis bullosa and children with so-called butterfly skin are currently treated by cleaning open wounds and bandaging them. This could soon change.