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calendar

8 catalysts · 18,987 approval · 6,833 phase readout · 5,000 device 510k · 4,728 grant · 3,499 8k filing · 2,000 device pma

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type: pdufa×type: adcom×clear all
type
  • approval18,987
  • phase readout6,833
  • device 510k5,000
  • grant4,728
  • 8k filing3,499
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings584
  • therapy area
    • Dermatology1
    • Infectious Disease1

    Week of Apr 27, 2026

    4
    ›Apr 27, 2026pdufa120d agoRegeneron Pharmaceuticals Inc — dupilumab (PDUFA)dupilumab

    Therapy area: Dermatology. Indication: Chronic Urticaria

    full page →dupilumab →source: globaldata
    ›Apr 28, 2026pdufa119d agoMerck & Co Inc — (doravirine + islatravir hydrate) (PDUFA)(doravirine + islatravir hydrate)

    Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)

    full page →(doravirine + islatravir hydrate) →source: globaldata
    ›Apr 29, 2026pdufa118d agoSanofi — teplizumab (PDUFA)teplizumab

    Therapy area: Metabolic Disorders. Indication: Type 1 Diabetes (Juvenile Diabetes)

    full page →teplizumab →source: globaldata
    ›Apr 30, 2026pdufa117d agoAxsome Therapeutics Inc — (bupropion hydrochloride + dextromethorphan) ER (PDUFA)(bupropion hydrochloride + dextromethorphan) ER

    Therapy area: Central Nervous System. Indication: Dementia Associated With Alzheimer's Disease

    full page →(bupropion hydrochloride + dextromethorphan) ER →source: globaldata

    Week of Jul 13, 2026

    1
    ›Jul 17, 2026pdufa39d agoPDUFA — 2026-07-17

    Prescription Drug User Fee Act goal date of July 17, 2026

    full page →pdufa extract ↗

    Week of Aug 3, 2026

    1
    ›08/07/2026adcom18d agoAdvisory Committee Calendar

    This page contains notices of advisory committee meetings. Refer to the individual meeting link below for more information on the anticipated format of each meeting. For previous years' advisory committee calendars, see the FDA Archive.

    full page →fda adcom ↗

    Week of Jan 4, 2027

    1
    ›Jan 4, 2027pdufa132dPDUFA — 2027-01-04

    action date of January 4, 2027

    full page →pdufa extract ↗

    Week of Jan 18, 2027

    1
    ›Jan 21, 2027pdufa149dPDUFA — 2027-01-21Ultragenyx Pharmaceutical Inc.

    action date of Jan. 21, 2027

    full page →pdufa extract ↗
    $REGN825.55-1.02%
    $MRK150.64-1.25%
    $SNY45.60-0.53%
    $RARE25.77-0.24%
    $AXSM206.55-0.59%