September 2026 FDA PDUFA Calendar: Drug Approval Dates & Deadlines
Track September 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 September 2026
Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in September 2026, sourced from FDA primary records.
Tracking 11 published FDA PDUFA decisions, including 8 NDAs and 3 BLAs.
| Sponsor | Product | Type | Application | PDUFA date | Status | Expand and copy |
|---|---|---|---|---|---|---|
| Advicenne | Sibnayal | NDA | PENDING-provisional|advicenne|sibnayal|distalrenaltubula | upcoming | ||
| Telix Pharmaceuticals | TLX101-Px (Pixclara) | NDA | PENDING-provisional|telixpharmaceuticals|tlx101pxpixclar | upcoming | ||
| Nuvalent | zidesamtinib | NDA | PENDING-provisional|nuvalent|zidesamtinib|ros1positiveno | upcoming | ||
| Ultragenyx Pharmaceutical | UX111 | BLA | PENDING-provisional|ultragenyxpharmaceutical|ux111|sanfi | upcoming | ||
| Merck | WINREVAIR | BLA | PENDING-provisional|merck|winrevair|pulmonaryarterialhyp | upcoming | ||
| Ionis Pharmaceuticals | zilganersen | NDA | PENDING-provisional|ionispharmaceuticals|zilganersen|ale | upcoming | ||
| Incyte Corporation / Mirum Pharmaceuticals | Zilurgisertib | NDA | PENDING-provisional|incytecorporationmirumpharmaceutical | upcoming | ||
| Praxis Precision Medicines | relutrigine | NDA | PENDING-provisional|praxisprecisionmedicines|relutrigine | upcoming | ||
| Biofrontera | Ameluz-PDT | NDA | PENDING-provisional|biofrontera|ameluzpdt|superficialbas | upcoming | ||
| Egetis Therapeutics | Emcitate (tiratricol) | NDA | PENDING-provisional|egetistherapeutics|emcitatetiratrico | upcoming | ||
| Scholar Rock | apitegromab | BLA | PENDING-provisional|scholarrock|apitegromab|spinalmuscul | upcoming |
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