Key Takeaways
- Six novel agents are due for FDA decisions in April 2025, stemming from different disease areas such as ophthalmology, immunology, vaccines, cancer imaging, and cardio-metabolic disease.
- Sanofi seeks a big population indication for Dupixent, which is on its second review cycle for chronic spontaneous urticaria, along with Aldeyra’s reproxalap for dry eye, also on its second review cycle, and Novavax/Sanofi’s COVID-19 vaccine.
- Stealth’s elamipretide is hoping for approval for Barth syndrome after a rocky history with the FDA and close advisory committee vote.
“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee goal dates are for new indications on sometimes sprawling labels,...
Twelve prescription drug user fee (PDUFA) goal dates are on the US FDA’s April 2025 calendar, according to the Pink Sheet FDA Performance Tracker’s User Fee Goal Dates tracker. (See...