NOTE (March 31, 2026 audit): This entry contained an error. Nipocalimab was approved by FDA as IMAAVY® (nipocalimab-aahu) for generalized myasthenia gravis (gMG) in 2025 — NOT for HDFN with a Feb 2026 PDUFA. The HDFN program (AZALEA Phase 3 trial) is still actively enrolling as of March 2026; no HDFN BLA has been filed. JNJ filed a separate supplemental application for wAIHA (warm autoimmune hemolytic anemia) on Feb 24, 2026. This entry is retained for reference but does not represent an active PDUFA date.
⚠️ 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.
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