How many FDA decisions (PDUFA dates) are in July 2027?

No PDUFA date is tracked for July 2027 as of November 6, 2026.

What is a PDUFA date?

The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

June 2027

PDUFA Dates July 2027

Updated November 6, 2026

August 2027

These dates are public. The filterable calendar, alerts, exports and AI research are in the app — free account: the next 7 days and 3 companies you track. Plans →

No PDUFA date is tracked for July 2027 yet. Each row shows the drug, company, indication, status and how firm the date is.

117

Total Catalysts

PDUFA Dates

116

Trial Results

Companies

Week 1Jun 28 - Jul 4(6 catalysts)

RGNX$506MBLA Filing

8mo

BLA Filing — RGX-202

Jul 1AI-detected

00%

Source

Q3 2027~QGMABEpcoritamab Phase 2 Est. ReadoutPhase 2
Q3 2027~QUTHRInhaled Treprostinil (Tyvaso Nebulizer) Phase 2 Est. ReadoutPhase 2
Q3 2027~QRHHBYLetrozole Phase 3 Est. ReadoutPhase 3
Q3 2027~QVKTXVK2735 Phase 3 Est. ReadoutPhase 3
Q3 2027~QAZNALXN1920 Phase 2 Est. Readout (AUTUMN)Phase 2

Week 2Jul 5 - Jul 11(9 catalysts)

Q3 2027~QAMGNTarlatamab Phase 3 Est. Readout (DeLLphi-305)Phase 3
Q3 2027~QHLUYYEptinezumab Phase 3 Est. Readout (PROSPECT-1)Phase 3
Q3 2027~QREGNREGN5093 Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNAZD2389 Phase 2 Est. Readout (BRAVO)Phase 2
Q3 2027~QKLRAKAI-7535 Phase 2 Est. ReadoutPhase 2
Q3 2027~QSNYriliprubart Phase 3 Est. Readout (VITALIZE)Phase 3
Q3 2027~QGSKmRNA Seasonal Flu vaccine Phase 3 Est. ReadoutPhase 3
Q3 2027~QHNPHYHS-10516 + Lenvatinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QMRKLiposomal doxorubicin Phase 3 Est. ReadoutPhase 3

Week 3Jul 12 - Jul 18(55 catalysts)

Q3 2027~QMRKBomedemstat Phase 3 Est. ReadoutPhase 3
Q3 2027~QBIOI-B.STBI-1910 Phase 2 Est. ReadoutPhase 2
Jul 2027~KPTISelinexor Phase 2 Est. ReadoutPhase 2
Jul 2027~ARWRARO-DIMERPA Phase 2 Est. ReadoutPhase 2
Jul 2027~KRYSKB707 Phase 2 Est. ReadoutPhase 2
Jul 2027~BIIBPegcetacoplan Phase 3 Est. ReadoutPhase 3
Q3 2027~QABBVVenetoclax Phase 3 Est. ReadoutPhase 3
Jul 2027~COAGHMB-002 (Part A) Phase 2 Est. ReadoutPhase 2
Jul 2027~SKBBYSKB264 Phase 3 Est. ReadoutPhase 3
Jul 2027~ALKSALKS 7290 Phase 2 Est. ReadoutPhase 2
Jul 2027~NTLAnexiguran ziclumeran Phase 3 Est. ReadoutPhase 3
Jul 2027~JHPCYSHR4640 ；Febuxostat Phase 2 Est. ReadoutPhase 2
Jul 2027~SKBBYBL-B01D1 Phase 2 Est. ReadoutPhase 2
Jul 2027~TVTXPegtibatinase Phase 2 Est. ReadoutPhase 2
Jul 2027~NBIXNBI-1065845 Phase 3 Est. ReadoutPhase 3
Jul 2027~SOBI.STEmapalumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZTRATR04-484 Phase 2 Est. ReadoutPhase 2
Jul 2027~YMABhumanized anti-GD2 antibody Phase 2 Est. ReadoutPhase 2
Q3 2027~QINCYEpacadostat Phase 2 Est. ReadoutPhase 2
Jul 2027~LLYAbemaciclib Phase 2 Est. ReadoutPhase 2
Jul 2027~JHPCYSHR4640 Phase 2 Est. ReadoutPhase 2
Jul 2027~MRKPembrolizumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNAcalabrutinib Phase 3 Est. Readout (MAJIC)Phase 3
Jul 2027~TXMDANG003 Dose A Phase 2 Est. ReadoutPhase 2
Jul 2027~BMYIpilimumab Phase 2 Est. ReadoutPhase 2
Jul 2027~SWTOYPacritinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QMRKPembrolizumab Phase 3 Est. ReadoutPhase 3
Jul 2027~NVSTisagenlecleucel Phase 2 Est. ReadoutPhase 2
Jul 2027~MGNXLorigerlimab Phase 2 Est. ReadoutPhase 2
Jul 2027~BGNEHIPEC Phase 2 Est. ReadoutPhase 2
Q3 2027~QBGNELuteinizing Hormone Releasing Hormone Phase 2 Est. ReadoutPhase 2
Jul 2027~PFEbrentuximab vedotin Phase 2 Est. ReadoutPhase 2
Jul 2027~MRKPembrolizumab/Olaparib Phase 2 Est. ReadoutPhase 2
Jul 2027~YMAB131 I-omburtamab Phase 2 Est. ReadoutPhase 2
Jul 2027~INCYRuxolitinib Phase 2 Est. ReadoutPhase 2
Jul 2027~EXELCabozantinib Phase 2 Est. ReadoutPhase 2
Jul 2027~NGENNVG-291 Phase 3 Est. Readout (RESTORE)Phase 3
Jul 2027~SNYIsatuximab Phase 2 Est. ReadoutPhase 2
Jul 2027~BMRNCipaglucosidase alfa Phase 3 Est. Readout (ROSSELLA)Phase 3
Jul 2027~LLYRetatrutide Phase 3 Est. Readout (TRIUMPH-8)Phase 3
Q3 2027~QSNYMRI contrast-enhancing preparations Phase 3 Est. Readout (Frexcite)Phase 3
Jul 2027~LLYLY4065967 Phase 2 Est. Readout (NP07)Phase 2
Jul 2027~ABBVCombined Oral Contraceptive Phase 3 Est. Readout (ELARIS EM-COC)Phase 3
Jul 2027~ALVOAVT29 (proposed aflibercept HD biosimilar) Phase 3 Est. Readout (ALVOEYE-HD)Phase 3
Jul 2027~ARGXEfgartigimod PH20 SC Phase 3 Est. Readout (Unity)Phase 3
Jul 2027~ABBVElagolix Phase 3 Est. Readout (ELARIS EM-COC)Phase 3
Jul 2027~GILDKTE-X19 Phase 2 Est. Readout (JKART-1)Phase 2
Jul 2027~MESORexlemestrocel-L + HA mixture Phase 3 Est. Readout (HyaluronicAcid)Phase 3
Jul 2027~IRONDISC-3405 Phase 2 Est. ReadoutPhase 2
Jul 2027~CRISEmavusertib Phase 2 Est. ReadoutPhase 2
Jul 2027~ABBVUpadacitinib (ABT-494) Phase 3 Est. Readout (U-ACTIVATE)Phase 3
Q3 2027~QBMYLuspatercept Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSJSB462 Phase 2 Est. ReadoutPhase 2
Q3 2027~QTXMDTiratricol Phase 2 Est. ReadoutPhase 2
Q3 2027~QAMGNAvacopan Phase 3 Est. ReadoutPhase 3

Week 4Jul 19 - Jul 25(11 catalysts)

Q3 2027~QMRKPembrolizumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QRHHBYPDS Implant Pre-Filled with Ranibizumab Phase 3 Est. Readout (Pagoda)Phase 3
Q3 2027~QDSKYFIfinatamab deruxtecan Phase 2 Est. ReadoutPhase 2
Q3 2027~QREC.MILCI699 Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSEYU688 Phase 2 Est. ReadoutPhase 2
Q3 2027~QVRTXVX-407 Phase 2 Est. Readout (AGLOW)Phase 2
Q3 2027~QPFEPF-07248144 Phase 3 Est. ReadoutPhase 3
Q3 2027~QGSKDostarlimab Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSLXE408 Phase 2 Est. ReadoutPhase 2
Q3 2027~QMRKMK-8527 Phase 3 Est. ReadoutPhase 3
Q3 2027~QSNYRilzabrutinib Phase 3 Est. Readout (LIBRA)Phase 3

Week 5Jul 26 - Aug 1(36 catalysts)

Q3 2027~QAZNBaxdrostat Phase 3 Est. Readout (BaxPA)Phase 3
Q3 2027~QAZNDato-DXd Phase 3 Est. ReadoutPhase 3
Q3 2027~QNVSGXV813 Phase 2 Est. ReadoutPhase 2
Q3 2027~QTPSTIO-108 Phase 2 Est. Readout (MORPHEUS-LIVER)Phase 2
Q3 2027~QAZNVolrustomig Phase 2 Est. Readout (eVOLVE-01)Phase 2
Q3 2027~QMRKMK-3120 Phase 2 Est. ReadoutPhase 2
Q3 2027~QPFERitlecitinib Phase 3 Est. Readout (Tranquillo 2)Phase 3
Q3 2027~QBAYRYDarolutamide (BAY1841788, Nubeqa) Phase 3 Est. Readout (ARASTEP)Phase 3
Q3 2027~QAZNLaroprovstat/Rosuvastatin 1 Phase 3 Est. ReadoutPhase 3
Q3 2027~QONCYPelareorep Phase 2 Est. Readout (GOBLET)Phase 2
Q3 2027~QADAGTobemstomig Phase 2 Est. Readout (MORPHEUS-LIVER)Phase 2
Q3 2027~QINCYINCB000928 Phase 2 Est. Readout (Progress)Phase 2
Q3 2027~QRHHBYGlofitamab Phase 2 Est. Readout (PORTAL)Phase 2
Q3 2027~QNVSIanalumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QJNJDaratumumab Phase 3 Est. Readout (MonumenTAL-3)Phase 3
Q3 2027~QGMABAcasunlimab Phase 3 Est. ReadoutPhase 3
Q3 2027~QADAGTPST-1120 Phase 2 Est. ReadoutPhase 2
Q3 2027~QRHHBYAtezolizumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNLaroprovstat Phase 3 Est. ReadoutPhase 3
Q3 2027~QNVSCapmatinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSGlycopyrronium bromide Phase 2 Est. ReadoutPhase 2
Q3 2027~QEXELCabozantinib Phase 2 Est. ReadoutPhase 2
Q3 2027~QGILDAxi-cel Phase 2 Est. ReadoutPhase 2
Q3 2027~QRHHBYRO7126209 Phase 2 Est. ReadoutPhase 2
Q3 2027~QAZNTremelimumab Phase 2 Est. ReadoutPhase 2
Q3 2027~QRHHBYRibociclib Phase 2 Est. ReadoutPhase 2
Q3 2027~QKYNBFOR46 Phase 2 Est. ReadoutPhase 2
Q3 2027~QTGTXUblituximab Phase 2 Est. ReadoutPhase 2
Q3 2027~QNVSRibociclib Phase 3 Est. ReadoutPhase 3
Q3 2027~QESLAEB103 Phase 2 Est. Readout (STARLIGHT-1)Phase 2
Q3 2027~QTXMDUblituximab Phase 2 Est. ReadoutPhase 2
Q3 2027~QMAIA6-Thio-2'-Deoxyguanosine Phase 3 Est. ReadoutPhase 3
Q3 2027~QAMGNABP 938 Phase 3 Est. ReadoutPhase 3
Q3 2027~QSGIOYSecutrelvir Phase 3 Est. ReadoutPhase 3
Q3 2027~QREGNUbamatamab Phase 2 Est. ReadoutPhase 2
Q3 2027~QANNXVonaprument Phase 3 Est. Readout (ARCHER II)Phase 3

June 2027 Full Calendar August 2027

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PDUFA dates July 2027: questions

How many FDA decisions (PDUFA dates) are in July 2027?: No PDUFA date is tracked for July 2027 as of November 6, 2026.
What is a PDUFA date?: The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

About PDUFA Dates in July 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for July 2027. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).

Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.

Learn more about PDUFA dates or view the full biotech catalyst calendar.