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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Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.