FDA Approvals
FDA approval decisions mark the culmination of the drug development process. An approved drug can be commercially marketed in the United States, often transforming a biotech company's revenue trajectory.
23 fda approvals tracked, next on Jul 29, 2026. Updated .
PDUFA Date: tividenofusp alfa
Denali Therapeutics Inc. (DNLI)
PDUFA Date: rp1
Replimune Group, Inc. (REPL)
PDUFA Date: filspari
Travere Therapeutics, Inc. (TVTX)
PDUFA Date: daraxonrasib
Royalty Pharma plc (RPRX)
PDUFA Date: gtx-104 for formal review
Grace Therapeutics, Inc. (GRCE)
PDUFA Date: jakafi xr
Incyte Corp. (INCY)
PDUFA Date: veppanu
ARVINAS, INC. (ARVN)
PDUFA Date: venetoclax
DR REDDYS LABORATORIES LTD (RDY)
PDUFA Date: afrezza
MANNKIND CORP (MNKD)
PDUFA Date: ctx-1301
Cingulate Inc. (CING)
PDUFA Date: vepdegestrant
ARVINAS, INC. (ARVN)
PDUFA Date: ons-5010
Outlook Therapeutics, Inc. (OTLK)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: dtx401 aav gene therapy
Ultragenyx Pharmaceutical Inc. (RARE)
PDUFA Date: zilganersen
IONIS PHARMACEUTICALS INC (IONS)
PDUFA Date: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
PDUFA Date: ino-3107
INOVIO PHARMACEUTICALS, INC. (INO)
PDUFA Date: igalmi
BioXcel Therapeutics, Inc. (BTAI)
PDUFA Date: ivonescimab
Summit Therapeutics Inc. (SMMT)
PDUFA Date: lorundrostat
Mineralys Therapeutics, Inc. (MLYS)
PDUFA Date: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
PDUFA Date: ulixacaltamide hcl
Praxis Precision Medicines, Inc. (PRAX)
PDUFA Date: ozekibart
Inhibrx Biosciences, Inc. (INBX)
Frequently asked questions
What is an FDA drug approval?
It is the FDA's authorization for a drug to be marketed in the United States after review of a New Drug Application (NDA) or Biologics License Application (BLA).
What is a Complete Response Letter (CRL)?
A CRL is the FDA's decision not to approve an application in its current form, citing deficiencies the sponsor must address before resubmission.
How current is the approvals calendar?
It is updated hourly with FDA decisions and the upcoming PDUFA dates that precede them.
Learn more
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