FDA Calendar
Upcoming Advisory Committee meetings and PDUFA dates.
Jan 5
PDUFA Decision
PDUFA: Tividenofusp (Denali Therapeutics)
BLA decision for Hunter syndrome (MPS II) treatment. Priority Review.
Jan 10
PDUFA Decision
PDUFA: Tabelecleucel (Atara Biotherapeutics)
BLA decision for Epstein-Barr virus positive PTLD.
Jan 23
Advisory Committee
Oncologic Drugs Advisory Committee (ODAC)
Discussing new drug applications for metastatic breast cancer.
Jan 31
PDUFA Decision
PDUFA: Anaphylm (Aquestive Therapeutics)
Decision on Anaphylm (dibutepinephrine) sublingual film for Anaphylaxis.
Feb 8
PDUFA Decision
PDUFA: RGX-121 (Regenxbio)
Priority review for RGX-121 for the treatment of MPS II.
Feb 28
PDUFA Decision
PDUFA: Dupixent (Sanofi/Regeneron)
sBLA for Allergic Fungal Rhinosinusitis (AFRS).