← Back to Calendar

PYLARIFY (piflufolastat F-18)

Lantheus Holdings · $LNTH
Standard Review sNDA
PDUFA Date
March 6, 2026
Time Remaining
18d ago
Review Type
Standard (10 mo)
92%
Baseline PoA
Historical sNDA
approval rate
Dynamic PoA
Coming soon
xAI Sentiment

Indication

PSMA PET imaging — new formulation for prostate cancer

Key Notes

New drug application for a new formulation of PYLARIFY PSMA PET imaging agent.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.
← Back to Full Calendar
Advertisement