FDA Calendar

Upcoming FDA decisions, clinical catalysts and important regulatory events.

2 events from 2026-10-30 to 2026-10-30

Symbol	Target Date	Drug	Status	Catalyst Type	News
PFE	Q4 2026	TALZENNA® (talazoparib) + XTANDI® (enzalutamide)	supplemental New Drug Application (sNDA) Priority Review	PDUFA	View
	Pfizer (PFE) said the U.S. Food and Drug Administration accepted for Priority Review its supplemental New Drug Application seeking to expand the use of TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). The FDA assigned a PDUFA target action date in the fourth quarter of 2026.
INO	30-Oct-2026	INO-3107	Biologics License Application (BLA)	PDUFA	View
	INOVIO (INO) revealed that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis (RRP). The application was granted a Standard Review, with the FDA setting a Prescription Drug User Fee Act (PDUFA) target action date of Oct. 30, 2026.