FDA Calendar - PDUFA Dates & AdCom Meetings

21 PDUFA dates + 0 Advisory Committee meetings

21

Upcoming

0

Approved

0

AdCom

Apr 3, 2026

Next PDUFA

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the target date by which the FDA commits to making a decision on a drug application (NDA or BLA). These dates are set when the FDA accepts a drug application for review.

Standard Review: 10 months from submission acceptance
Priority Review: 6 months from submission acceptance
Outcome: Approval, Complete Response Letter (CRL), or extension

i

Data Source: SEC 8-K Filings

PDUFA dates are extracted from company SEC 8-K filings where companies announce FDA acceptance of their drug applications. This provides authentic, primary-source data directly from regulatory filings.

Last updated: March 29, 2026

Next Decision 5 days away

Biogen Inc.

BIIB

nusinersen (high dose)

Apr 3, 2026

View SEC Filing

Upcoming PDUFA Dates by Month

April 2026

Biogen Inc. BIIB

nusinersen (high dose)

Spinal muscular atrophy

Apr 3, 2026

5 days

Ionis Pharmaceuticals Inc. IONS

SPINRAZA (higher dose)

Spinal muscular atrophy

Apr 3, 2026

5 days

Replimune Group, Inc. REPL

RP1 (vusolimogene oderparepvec) + nivolumab

Advanced melanoma (anti-PD-1 refractory)

Apr 10, 2026

12 days

Theriva Biologics, Inc. TOVX

Metastatic pancreatic cancer

Apr 10, 2026

12 days

Axsome Therapeutics, Inc. AXSM

AXS-05 (dextromethorphan-bupropion)

Major depressive disorder

Apr 30, 2026

32 days

May 2026

MannKind Corporation MNKD

Technosphere Insulin (Afrezza)

Diabetes mellitus

May 29, 2026

61 days

Cingulate Inc. CING

CTx-1301 (dexmethylphenidate)

Attention-Deficit/Hyperactivity Disorder (ADHD)

May 31, 2026

63 days

June 2026

Arvinas, Inc. ARVN

ARV-471 (vepdegestrant)

ER+/HER2- breast cancer

Jun 5, 2026

68 days

Achieve Life Sciences, Inc. ACHV

Smoking cessation

Jun 20, 2026

83 days

Lantheus Holdings, Inc. LNTH

LNTH-2501 (Gallium 68 edotreotide)

PET imaging for neuroendocrine tumors (NETs)

Jun 29, 2026

92 days

Arcutis Biotherapeutics, Inc. ARQT

ZORYVE (roflumilast) cream 0.3%

Plaque psoriasis (children ages 2-5)

Jun 29, 2026

92 days

July 2026

Vera Therapeutics, Inc. VERA

IgA nephropathy

Jul 7, 2026

100 days

Corcept Therapeutics Inc. CORT

Ovarian cancer

Jul 11, 2026

104 days

August 2026

Capricor Therapeutics, Inc. CAPR

Deramiocel (CAP-1002)

Duchenne muscular dystrophy (DMD) cardiomyopathy

Aug 22, 2026

146 days

September 2026

Roivant Sciences Ltd. ROIV

Dermatomyositis

Sep 30, 2026

185 days

October 2026

Opus Genetics, Inc. IRD

Phentolamine ophthalmic solution 0.75%

Presbyopia

Oct 17, 2026

202 days

Inovio Pharmaceuticals, Inc. INO

Cervical intraepithelial neoplasia (CIN)

Oct 30, 2026

215 days

November 2026

Summit Therapeutics Inc. SMMT

Non-small cell lung cancer

Nov 14, 2026

230 days

December 2026

Exelixis, Inc. EXEL

Zanzalintinib (XL-092)

Hepatocellular carcinoma

Dec 3, 2026

249 days

Hansa Biopharma AB HNSA

Kidney transplant desensitization (highly sensitized patients)

Dec 19, 2026

265 days

Arcellx, Inc. ACLX

Anitocabtagene autoleucel (anito-cel)

Multiple myeloma

Dec 23, 2026

269 days

Recent Decisions (Last 6 Months)

0 approved, 25 pending outcome

March 2026

Rocket Pharmaceuticals, Inc. RCKT PENDING

Kresladi (marnetegragene autotemcel)

Mar 28, 2026

1 days ago

Septerna Inc. SEPN PENDING

Mar 24, 2026

5 days ago

Rhythm Pharmaceuticals, Inc. RYTM PENDING

IMCIVREE (setmelanotide)

Mar 20, 2026

9 days ago

Aldeyra Therapeutics, Inc. ALDX PENDING

Mar 16, 2026

13 days ago

February 2026

Eton Pharmaceuticals, Inc. ETON PENDING

ET-600/DESMODA (desmopressin oral solution)

Feb 25, 2026

32 days ago

REGENXBIO Inc. RGNX PENDING

RGX-121 (clemidsogene lanparvovec)

Feb 8, 2026

49 days ago

January 2026

Aquestive Therapeutics, Inc. AQST PENDING

Anaphylm (dibutepinephrine sublingual film)

Jan 31, 2026

57 days ago

Atara Biotherapeutics, Inc. ATRA PENDING

Tabelecleucel (Tab-cel)

Jan 10, 2026

78 days ago

Denali Therapeutics Inc. DNLI PENDING

Tividenofusp Alfa (DNL310)

Jan 5, 2026

83 days ago

Glaukos Corp GKOS PENDING

iDose TR (Travoprost Intraocular Implant)

Jan 1, 2026

87 days ago

December 2025

Outlook Therapeutics, Inc. OTLK PENDING

ONS-5010/LYTENAVA (bevacizumab-vikg)

Dec 31, 2025

88 days ago

Corcept Therapeutics Inc. CORT PENDING

Dec 30, 2025

89 days ago

Cytokinetics Inc. CYTK PENDING

MYQORZO (aficamten)

Dec 26, 2025

93 days ago

Omeros Corp OMER PENDING

YARTEMLEA (narsoplimab)

Dec 26, 2025

93 days ago

Aldeyra Therapeutics, Inc. ALDX PENDING

Dec 16, 2025

103 days ago

Innoviva, Inc. INVA PENDING

Dec 15, 2025

104 days ago

Milestone Pharmaceuticals Inc. MIST PENDING

CARDAMYST (etripamil nasal spray)

Dec 13, 2025

106 days ago

BioCryst Pharmaceuticals Inc. BCRX PENDING

BCX17725 (oral Factor D inhibitor)

Dec 12, 2025

107 days ago

Agios Pharmaceuticals, Inc. AGIO PENDING

AQVESME (mitapivat)

Dec 7, 2025

112 days ago

Axogen, Inc. AXGN PENDING

AVANCE (acellular nerve allograft)

Dec 5, 2025

114 days ago

November 2025

Kura Oncology, Inc. KURA PENDING

Nov 30, 2025

119 days ago

Arrowhead Pharmaceuticals, Inc. ARWR PENDING

REDEMPLO (plozasiran)

Nov 18, 2025

131 days ago

October 2025

Arcutis Biotherapeutics, Inc. ARQT PENDING

ZORYVE (roflumilast) cream 0.05%

Oct 13, 2025

167 days ago

Jazz Pharmaceuticals plc JAZZ PENDING

Zepzelca (lurbinectedin) + atezolizumab

Oct 7, 2025

173 days ago

September 2025

Fortress Biotech, Inc. FBIO PENDING

CUTX-101 (ZYCUBO)

Sep 30, 2025

180 days ago

Data Collection Methodology

Search SEC EDGAR for 8-K filings containing "PDUFA"
Extract PDUFA target dates using pattern matching
Parse drug names from filing context where available
Deduplicate by company (keeping most recent filing)

Limitations: Not all companies file 8-Ks announcing PDUFA dates. Some dates may be from historical context in filings. Drug names may not always be extractable.