What you need to know about the FDA’s most recent novel drug approvals.
FDA Approves Chenodiol for Treatment of Cerebrotendinous Xanthomatosis
Ctexli is the first FDA-approved treatment for adults with cerebrotendinous xanthomatosis.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
FDA Grants Breakthrough Therapy Designation to SkinTE for Wagner Grade 1 Diabetic Foot Ulcers
By 12 weeks, investigators report that SkinTE facilitated significantly more wound closures compared with the standard of care.
FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia
The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.
FDA to Evaluate Lenacapavir for Prevention of HIV
A PDUFA target action date for the PrEP therapy has been set for June 19, 2025.
FDA Accepts sBLA for Dupilumab for Bullous Pemphigoid
Previously, dupilumab (Dupixent) received orphan drug designation for bullous pemphigoid.
