US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA
Executive Summary
Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.
You may also be interested in...
Keeping Track: US FDA Approves Carvykti, Vonjo, But Turns Down Lenacapavir, Filsuvez And GC1507
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
November Could See US FDA Action On Five Breakthrough Applications, Nine Novel Agents
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.
Butterfly Skin Therapy Pipeline Primed For Transformation
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.