As of Oct 28, 2026: 5 dates on the FDA calendar in December 2025: 5 approved. Scores as of 4:51 AM ET, 15 minutes behind.

FDA decisions in December 2025

PDUFA dates and FDA panels

Decision dates5in December Approved5announced FDA letters0announced

FDA dates in December 2025

With each outcome the company announced

FDA decision dates and panels in December 2025, each with the company's Quality Score and cash runway
Date	Stock	Drug	Cash runway	Quality Score
December 20255
December 20255
December 20255
	BCRXApprovedBioCryst PharmaceuticalsApprovedBrings in cash	Drug not namedPDUFA date	Brings in cashBalance Jun 30	6
	MISTApprovedMilestone PharmaceuticalsApprovedCash: into H2 2027	Drug not namedPDUFA date	Into H2 2027The company's words	Not scored
	INVAApprovedInnovivaApprovedBrings in cash	Drug not namedPDUFA date	Brings in cashBalance Jun 30	5
	AMGNApprovedAmgenApprovedBrings in cash	Drug not namedPDUFA date	Brings in cashBalance Jun 30	20
	OMERApprovedOmerosApprovedRunway not counted	Drug not namedPDUFA date	Not countedBalance Jun 30	7

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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December 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 December 2025, Oct 28, 2026, getbreakaway.com/biotech/2025-12

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

The FDA calendar.