pdufa.bio
HomePDUFA Calendar › ALPMY

ALPMY FDA calendar & decision history

Astellas Pharma Inc. ADR · 1 upcoming · 3 past FDA decisions

Upcoming FDA catalysts

ALPMY · Aug 17, 2026KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) - (KEYNOTE-B15/EV-304) — Muscle-invasive bladder cancer (MIBC)

FDA decision history (3)

Dec 17, 2025✕ CRLFDA decisionNov 21, 2025✓ ApprovedFDA decisionFeb 13, 2025✓ ApprovedFDA decision
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates ALPMY's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.