As of Oct 28, 2026: 2 dates on the FDA calendar in November 2025: 2 approved. Scores as of 5:52 AM ET, 15 minutes behind.

FDA decisions in November 2025

PDUFA dates and FDA panels

Decision dates2in November Approved2announced FDA letters0announced

FDA dates in November 2025

With each outcome the company announced

FDA decision dates and panels in November 2025, each with the company's Quality Score and cash runway
Date	Stock	Drug	Cash runway	Quality Score
November 20252
November 20252
November 20252
	GMABApprovedGenmabApprovedRunway not counted	Drug not namedPDUFA date	Not countedBalance Dec 2025	16
	KURAApprovedKura OncologyApprovedRunway not counted	ZiftomenibPDUFA date	Not countedBalance Jun 30	0

Pro members also see whether each company's cash lasts past its date, how its stock moved on past FDA news, and filters by area, phase, and size, with an optional alert before each date.

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November 2025, by week

Use this page

Kept by Andrew Gomes, Breakaway's founder, from the companies' filings on the SEC's EDGAR, each date's filing linked on its row. Updated Oct 28, 2026.

Download the month's dates (PNG)Free to reuse with a link to this page.

How to cite

Breakaway, FDA decisions in November 2025, Oct 28, 2026, getbreakaway.com/biotech/2025-11

Journalists: email [email protected] for the data behind this page.

The FDA calendar.