When is the next FDA decision date?

The next FDA (PDUFA) decision BioRadar is tracking is OTLK on July 29, 2026, about 5 days away. There are 21 upcoming FDA decision dates in total, with 2 in the next 30 days.

What is a PDUFA date?

A PDUFA date is the FDA's target action date for deciding on a drug application, named after the Prescription Drug User Fee Act. On that date the FDA typically approves the drug, issues a Complete Response Letter (rejection), or extends the review. It is a target, not a guaranteed approval date.

How many FDA decisions are coming up in the next 90 days?

BioRadar is tracking 8 FDA (PDUFA) decision dates in the next 90 days, out of 21 upcoming decisions in total through May 2027.

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Upcoming FDA Decisions & PDUFA Dates

Every upcoming FDA drug-decision (PDUFA) date BioRadar is tracking, with approval-probability scores. Updated automatically — last refreshed July 24, 2026.

The next FDA decision is OTLK (Wet AMD) on July 29, 2026, 5 days away. BioRadar is tracking 21 upcoming PDUFA dates — 2 in the next 30 days and 8 in the next 90 days — through May 2027.

2Next 30 days

8Next 90 days

21Total upcoming

Jul 29Next decision

A PDUFA date is the FDA's target action date for deciding on a drug application. On that date the FDA typically approves the drug, issues a Complete Response Letter (rejection), or extends the review. These are binary, high-variance catalysts — see how biotech stocks have historically moved around FDA decisions.

July 2026 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Jul 29	OTLK	Wet AMD	BLA	89%	5d

August 2026 (3)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Aug 22	CAPR	rare diseases	BLA	85%	29d
Aug 25	JAZZ	—	sBLA	93%	32d
Aug 25	ZYME	first-line HER2-positive advanced GEA	sBLA	93%	32d

September 2026 (4)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Sep 18	NUVL	adult patients with locally advanced or metast	NDA	87%	56d
Sep 22	IONS	—	NDA	87%	60d
Sep 26	MIRM	—	NDA	87%	64d
Sep 30	SRRK	children and adults with spinal muscular atrop	BLA	89%	68d

October 2026 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Oct 30	INO	adults with Recurrent Respiratory Papillomatos	BLA	89%	98d

November 2026 (4)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Nov 14	SMMT	EGFRm NSCLC Post-TKI Therapy BLA Filing Based	BLA	89%	113d
Nov 14	CYTK	adults with symptomatic oHCM to improve functi	sNDA	92%	113d
Nov 14	BTAI	agitation associated with Alzheimer&rsquo	sNDA	84%	113d
Nov 27	BBIO	individuals living with LGMD2I/R9 and would re	NDA	87%	126d

December 2026 (3)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Dec 12	VNDA	Generalized Pustular	BLA	89%	141d
Dec 22	MLYS	hypertension in combination with other antihyp	NDA	87%	151d
Dec 23	GILD	Multiple Myeloma &ndash	BLA	83%	152d

January 2027 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Jan 29	PRAX	SCN2A and SCN8A-DEE and RPD designation for Dr	NDA	87%	189d

February 2027 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Feb 27	CGEM	—	NDA	87%	218d

April 2027 (1)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
Apr 14	INBX	Ozekibart — Unresectable or Metastatic Conventional Chondr	BLA	89%	264d

May 2027 (2)

Date	Ticker	Drug / Indication	Type	Approval odds	Countdown
May 1	AXSM	Cataplexy in Narcolepsy	NDA	87%	281d
May 8	BBIO	Encaleret — individuals living with autosomal dominant hyp	NDA	87%	288d

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Data: SEC & FDA filings • Approval odds are model estimates, not guarantees • Informational only, not investment advice. • Past FDA decisions & outcomes →