FDA PDUFA Calendar
The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates. These are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
The FDA will typically issue one of the following decisions:
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CRL - complete response letter - rejection letter noting reasons
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Marketing approval - approved to market under the given label
Sometimes the FDA requires an advisory committee meeting prior to the approval decision. This meeting is a public discussion with committee members of various relevant backgrounds, which usually concludes in a vote regarding the efficacy and safety of the drug in question. The FDA is may use this discussion and vote as a guideline for their decision but by no means are bound to this discussion or vote.
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Ticker | Drug | Indication | PDUFA Date |
|---|---|---|---|
SNY | Fitusiran | Hemophilia A or B | March 28, 2025 |
ALNY | FITUSIRAN | Hemophilia A/B | March 28, 2025 |
ALDX | Reproxalap (ADX-102) | DED (Dry Eye Disease) | April 2, 2025 |
ARGX | VYVGART SC pre-filled syringe (PFS) | generalized myasthenia gravis (gMG), CIDP | April 10, 2025 |
THTX | EGRIFTA SV® (tesamorelin for injection) | HIV-Associated Excess Abdominal Fat | April 18, 2025 |
BMY | Opdivo® (nivolumab) + Yervoy (ipilimumab) | Hepatocellular Carcinoma | April 21, 2025 |
ABEO | Pz-cel (prademagene zamikeracel) EB-101 (COL7A1) | Recessive Dystrophic Epidermolysis Bullosa (RDEB) | April 29, 2025 |
ARQT | ARQ-154 topical roflumilast foam 0.3% | Scalp and body psoriasis | May 22, 2025 |
LQDA | YUTREPIA (Treprostinil) (LIQ861) | PAH (Pulmonary Arterial Hypertension), PH-ILD (Pulmonary hypertension associated with interstitial lung disease) | May 23, 2025 |
MRK | WELIREG® (belzutifan) | Advanced pheochromocytoma and paraganglioma (PPGL) | May 26, 2025 |
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