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.
24 fda approvals tracked, next on Sep 22, 2026. Event dates and source records are shown with their available source context.
PDUFA Date: ctx-1301
Cingulate Inc. (CING)
FDA Decision: vp bla
DBV Technologies S.A. (DBVT)
PDUFA Date: vepdegestrant
ARVINAS, INC. (ARVN)
FDA Decision: prednisone
DR REDDYS LABORATORIES LTD (RDY)
FDA Decision: trutakna
Vera Therapeutics, Inc. (VERA)
FDA Decision: senti-202
Senti Biosciences, Inc. (SNTI)
FDA Decision: jideytro
Nuvalent, Inc. (NUVL)
FDA Decision: lytenava
Outlook Therapeutics, Inc. (OTLK)
PDUFA Date: ons-5010
Outlook Therapeutics, Inc. (OTLK)
FDA Decision: zenbexus
BRISTOL MYERS SQUIBB CO (BMY)
FDA Decision: pasatru
REGENERON PHARMACEUTICALS, INC. (REGN)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: dtx401 aav gene therapy
Ultragenyx Pharmaceutical Inc. (RARE)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: zilganersen
IONIS PHARMACEUTICALS INC (IONS)
PDUFA Date: ino-3107
INOVIO PHARMACEUTICALS, INC. (INO)
PDUFA Date: igalmi
BioXcel Therapeutics, Inc. (BTAI)
PDUFA Date: ivonescimab
Summit Therapeutics Inc. (SMMT)
PDUFA Date: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA Date: lorundrostat
Mineralys Therapeutics, Inc. (MLYS)
PDUFA Date: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
Revised from Sep 27, 2026
PDUFA Date: zeleciment rostudirsen (z-rostudirsen
Dyne Therapeutics, Inc. (DYN)
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?
Event dates and source records are shown with their available source context.
Learn more
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