Regulatory intelligence

FDA event calendar

Published, source-backed regulatory dates. Precision and provenance stay visible.

A company-disclosed PDUFA target date is distinct from an FDA decision. Dates can change. Only events that pass evidence review are published here; the calendar is not comprehensive.

Source coverage

Scans cover the tracked company and drug universe. Records without a clear entity match stay unpublished. A completed scan does not mean every FDA event is included.

Company-disclosed PDUFA dates (SEC): Last completed scan: 26 Sep 2026, 06:00 UTC.
CDER original approvals: Last completed scan: 26 Sep 2026, 05:58 UTC.
CBER original approvals: Last completed scan: 26 Sep 2026, 05:55 UTC.
FDA complete response letters: Last completed scan: 26 Sep 2026, 05:54 UTC.
FDA advisory committee notices: Last completed scan: 26 Sep 2026, 05:54 UTC.

Date / precision	Drug / sponsor	Event	Indication	Evidence
2026-02-13day	DISC-1459Disc Medicine, Inc · IRON	FDA complete response letter	Not specified	Primary source Evidence excerpt {"application_number": ["NDA 220707"], "letter_date": "02/13/2026", "letter_type": "COMPLETE RESPONSE", "company_name": "Disc Medicine, Inc.", "file_name": "CRL_NDA220707_20260213.pdf"} First seen: 26 Sep 2026 · Last verified: 26 Sep 2026
2026-03-16day	ADX-102 Ophthalmic Solution (0.5%)Aldeyra Therapeutics, Inc. · ALDX	FDA complete response letter	Not specified	Primary source Evidence excerpt {"application_number": ["NDA 216442"], "letter_date": "03/16/2026", "letter_type": "COMPLETE RESPONSE", "company_name": "Aldeyra Therapeutics, Inc.", "file_name": "CRL_NDA216442_20260316.pdf"} First seen: 26 Sep 2026 · Last verified: 26 Sep 2026
2026-06-29day	Oxylanthanum CarbonateUnicycive Therapeutics, Inc · UNCY	FDA complete response letter	Not specified	Primary source Evidence excerpt {"application_number": ["NDA 218607"], "letter_date": "06/29/2026", "letter_type": "COMPLETE RESPONSE", "company_name": "Unicycive Therapeutics Inc.", "file_name": "CRL_NDA218607_20260629.pdf"} First seen: 26 Sep 2026 · Last verified: 26 Sep 2026
2027-02-12day	TinlarebantBelite Bio, Inc · BLTE	Company-disclosed PDUFA goal date	Stargardt disease type 1	Primary source Evidence excerpt U.S. Food and Drug Administration accepted the New Drug Application with Priority Review for tinlarebant for the treatment of Stargardt disease type 1; Prescription Drug User Fee Act target action date of February 12, 2027 First seen: 26 Sep 2026 · Last verified: 26 Sep 2026
2027-05-01day	AXS-12 (reboxetine)Axsome Therapeutics, Inc. · AXSM	Company-disclosed PDUFA goal date	cataplexy in narcolepsy	Primary source Evidence excerpt Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy FDA sets PDUFA target action date of May 1, 2027 First seen: 25 Sep 2026 · Last verified: 25 Sep 2026

Dates are not outcomes

A target action date is a review milestone, not an approval guarantee. Month, quarter and year estimates are preserved at their disclosed precision.

A source for every event

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