Upcoming FDA Decisions
20 PDUFA decisions with a confirmed day in the next 12 months. Estimated windows are on the monthly PDUFA calendar; resolved decisions move to outcomes.
September 2026Full month calendar →
October 2026Full month calendar →
November 2026Full month calendar →
December 2026Full month calendar →
January 2027Full month calendar →
- Jan 3Efgartigimod — Postural Orthostatic Tachycardia SyndromeARGX
- Jan 4Taletrectinib — Non Small Cell Lung CancerNUVB
- Jan 10satralizumab — Neuromyelitis Optica Spectrum DisorderRHHBY
- Jan 18ET-105 — adult refractory gastroesophageal reflux disease (rGERD)ETON
- Jan 18HBS-102 — narcolepsyHRMY
- Jan 20OPX-102 — AchromatopsiaIRD