June 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines
Track June 2026 FDA PDUFA dates for NDA, BLA, ANDA, and IND decisions. Free drug approval tracker with source-linked deadlines, calendar views, and daily updates.
FDA PDUFA dates in June 2026
Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in June 2026, sourced from FDA primary records.
Tracking 10 published FDA PDUFA decisions, including 7 NDAs and 3 BLAs.
| Sponsor | Product | Type | Application | PDUFA date | Status | Expand and copy |
|---|---|---|---|---|---|---|
| Daiichi Sankyo and AstraZeneca | DATROWAY | BLA | PENDING-provisional|daiichisankyoandastrazeneca|datroway | overdue | ||
| Arvinas | vepdegestrant | NDA | PENDING-provisional|arvinas|vepdegestrant|esr1mutatederp | decided | ||
| GSK and Spero Therapeutics | tebipenem HBr | NDA | PENDING-provisional|gskandsperotherapeutics|tebipenemhbr | overdue | ||
| Merck | KEYTRUDA + WELIREG | BLA | PENDING-provisional|merck|keytrudawelireg|adjuvanttreatm | overdue | ||
| Achieve Life Sciences | cytisinicline | NDA | PENDING-provisional|achievelifesciences|cytisinicline|ni | overdue | ||
| Arcutis Biotherapeutics | ZORYVE cream 0.3% | NDA | PENDING-provisional|arcutisbiotherapeutics|zoryvecream03 | overdue | ||
| Lantheus | LNTH-2501 (Ga 68 edotreotide) | NDA | PENDING-provisional|lantheus|lnth2501ga68edotreotide|pet | overdue | ||
| Unicycive Therapeutics | oxylanthanum carbonate | NDA | PENDING-provisional|unicycivetherapeutics|oxylanthanumca | overdue | ||
| Ionis Pharmaceuticals | olezarsen | NDA | PENDING-provisional|ionispharmaceuticals|olezarsen|sever | overdue | ||
| Viridian Therapeutics | veligrotug | BLA | PENDING-provisional|viridiantherapeutics|veligrotug|thyr | overdue |
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