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.
16 fda approvals tracked, next on Nov 14, 2026. Event dates and source records are shown with their available source context.
PDUFA: SENTI-202
Senti Biosciences, Inc. (SNTI)
PDUFA: jideytro
Nuvalent, Inc. (NUVL)
PDUFA: lytenava
Outlook Therapeutics, Inc. (OTLK)
PDUFA: fexofenadine
DR REDDYS LABORATORIES LTD (RDY)
PDUFA: deramiocel
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA: rasonque
REVOLUTION MEDICINES, INC. (RVMD)
PDUFA: pomalidomide
DR REDDYS LABORATORIES LTD (RDY)
PDUFA: pixclara
Telix Pharmaceuticals Limited (TLX)
PDUFA: ivonescimab
Summit Therapeutics Inc. (SMMT)
PDUFA: 0001104659-26-100071
CAPRICOR THERAPEUTICS, INC. (CAPR)
PDUFA: lorundrostat
Mineralys Therapeutics, Inc. (MLYS)
PDUFA: relutrigine
Praxis Precision Medicines, Inc. (PRAX)
PDUFA: 0001193125-26-308343
Dyne Therapeutics, Inc. (DYN)
PDUFA: 0001689548-26-000033
Praxis Precision Medicines, Inc. (PRAX)
PDUFA: 0001193125-26-411011
Cullinan Therapeutics, Inc. (CGEM)
PDUFA: 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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From catalyst type to protocol condition
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