Upcoming PDUFA Dates
| Company | Date | Drug | Indication | |
|---|---|---|---|---|
RHYTHM PHARMACEUTICALS, INC. (RYTM) | 2024-12-26T00:00:00Z | imcivree | treat children as young as 2 years old in its approved indications | source |
Syndax Pharmaceuticals Inc (SNDX) | 2024-12-26T00:00:00Z | revumenib | adult and pediatric relapsed or refractory kmt2a-r acute leukemia | source |
SOLENO THERAPEUTICS INC (SLNO) | 2024-12-27T00:00:00Z | dccr (diazoxide choline) extended-release tablets | treatment of prader-willi syndrome (pws) | source |
Checkpoint Therapeutics, Inc. (CKPT) | 2024-12-28T00:00:00Z | cosibelimab | metastatic or locally advanced cscc | source |
Fortress Biotech, Inc. (FBIO) | 2024-12-28T00:00:00Z | cosibelimab | metastatic or locally advanced cutaneous squamous cell carcinoma | source |
Fortress Biotech, Inc. (FBIOP) | 2024-12-28T00:00:00Z | cosibelimab | metastatic or locally advanced cutaneous squamous cell carcinoma | source |
Mirum Pharmaceuticals, Inc. (MIRM) | 2024-12-28T00:00:00Z | chenodiol | cerebrotendinous xanthomatosis (ctx) | source |
BRISTOL MYERS SQUIBB CO (BMY) | 2024-12-29T00:00:00Z | cabozantinib | therapy | source |
HALOZYME THERAPEUTICS, INC. (HALO) | 2024-12-29T00:00:00Z | Opdivo | advanced or metastatic clear cell renal cell carcinoma | source |
NEUROCRINE BIOSCIENCES INC (NBIX) | 2024-12-29T00:00:00Z | crinecerfont | classic congenital adrenal hyperplasia (cah) | source |
EYENOVIA, INC. (EYEN) | 2024-12-30T00:00:00Z | mydcombi | not specified | source |
NEUROCRINE BIOSCIENCES INC (NBIX) | 2024-12-30T00:00:00Z | crinecerfont | classic congenital adrenal hyperplasia (cah) | source |
Roivant Sciences Ltd. (ROIV) | 2024-12-31T00:00:00Z | Vtama (tapinarof) cream | atopic dermatitis | source |
scPharmaceuticals Inc. (SCPH) | 2025-01-01T00:00:00Z | furoscix | edema due to fluid overload in patients with chronic kidney disease | source |
Vertex Pharmaceuticals Incorporated (VRTX) | 2025-01-02T00:00:00Z | vanzacaftor | cystic fibrosis | source |
Atara Biotherapeutics, Inc. (ATRA) | 2025-01-15T00:00:00Z | tab-cel | ebv+ ptld | source |
BIOGEN INC. (BIIB) | 2025-01-25T00:00:00Z | leqembi | early alzheimer's disease | source |
Vertex Pharmaceuticals Incorporated (VRTX) | 2025-01-30T00:00:00Z | suzetrigine | moderate-to-severe acute pain | source |
Axsome Therapeutics, Inc. (AXSM) | 2025-01-31T00:00:00Z | axs-07 | migraine | source |
SUPERNUS PHARMACEUTICALS, INC. (SUPN) | 2025-02-01T00:00:00Z | spn-830 | continuous treatment of motor fluctuations in Parkinson's disease | source |
HALOZYME THERAPEUTICS, INC. (HALO) | 2025-02-28T00:00:00Z | Opdivo | advanced or metastatic clear cell renal cell carcinoma | source |
SpringWorks Therapeutics, Inc. (SWTX) | 2025-02-28T00:00:00Z | mirdametinib | neurofibromatosis type 1-associated plexiform neurofibromas | source |
scPharmaceuticals Inc. (SCPH) | 2025-03-01T00:00:00Z | furoscix | edema due to fluid overload in patients with chronic kidney disease | source |
scPharmaceuticals Inc. (SCPH) | 2025-03-06T00:00:00Z | furosemide injection | chronic kidney disease (CKD) | source |
ARS Pharmaceuticals, Inc. (SPRY) | 2025-03-06T00:00:00Z | neffy 1 mg | type i allergic reactions, including anaphylaxis | source |
Milestone Pharmaceuticals Inc. (MIST) | 2025-03-27T00:00:00Z | etripamil | self-administered therapy for the rapid termination of episodes of SVT | source |
ALNYLAM PHARMACEUTICALS, INC. (ALNY) | 2025-03-28T00:00:00Z | fitusiran | hemophilia | source |
NOVAVAX INC (NVAX) | 2025-04-01T00:00:00Z | nvx-cov2601 | covid-19 | source |
EXELIXIS, INC. (EXEL) | 2025-04-03T00:00:00Z | cabozantinib | treatment of adult patients with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumors (pnet) or extra-pancreatic neuroendocrine tumors (epnet) | source |
BRISTOL MYERS SQUIBB CO (BMY) | 2025-04-21T00:00:00Z | Opdivo | Unresectable Hepatocellular Carcinoma | source |
ABEONA THERAPEUTICS INC. (ABEO) | 2025-04-29T00:00:00Z | bla | not specified | source |
Arcutis Biotherapeutics, Inc. (ARQT) | 2025-05-01T00:00:00Z | Zoryve | Psoriasis | source |
UroGen Pharma Ltd. (URGN) | 2025-06-13T00:00:00Z | ugn-102 | low-grade upper tract urothelial cancer | source |
KalVista Pharmaceuticals, Inc. (KALV) | 2025-06-17T00:00:00Z | sebetralstat | hae | source |
Unicycive Therapeutics, Inc. (UNCY) | 2025-06-28T00:00:00Z | Oxylanthanum Carbonate (OLC) | Hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis | source |
PTC THERAPEUTICS, INC. (PTCT) | 2025-07-29T00:00:00Z | sepiapterin | pku | source |
LENZ Therapeutics, Inc. (LENZ) | 2025-08-08T00:00:00Z | lnz100 | eye condition | source |
Ionis Pharmaceuticals, Inc. (IONS) | 2025-08-21T00:00:00Z | donidalorsen | hae | source |