PDUFA Calendar 2026

: PDUFA

: PDUFA Date

: 14.71%

: 80%

: Vepdegestrant (ARV-471) is an oral PROTAC ER degrader developed by Arvinas in collaboration with Pfizer, targeting ESR1-mutated ER+/HER2- advanced or metastatic breast cancer. The FDA accepted the New Drug Application (NDA) for vepdegestrant in August 2025, with a PDUFA action... Show more

: Estrogen receptor-positive (ER+)/HER2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer

: The FDA has assigned a PDUFA action date for the NDA of vepdegestrant, which is based on data from the pivotal Phase 3 VERITAC-2 clinical trial demonstrating significant improvement in progression-free survival.

: PDUFA

: PDUFA Date

: 107.58%

: 82%

: Cytisinicline, developed by Achieve Life Sciences (ACHV), is currently under FDA review, with its New Drug Application accepted on September 3, 2025, and a PDUFA date set for June 20, 2026. The drug targets nicotine dependence and smoking cessation, functioning... Show more

: Nicotine dependence, smoking cessation

: The FDA has accepted the New Drug Application (NDA) for cytisinicline, targeting a PDUFA date for potential approval as a new treatment for smoking cessation.

: PDUFA

: PDUFA Date

: -6.41%

: 100%

: ZORYVE (roflumilast) cream 0.3% is FDA approved for the treatment of plaque psoriasis in patients aged 6 years and older. The approval was granted in July 2022 based on the successful outcomes of two Phase 3 trials (DERMIS-1 and DERMIS-2)... Show more

: plaque psoriasis

: The FDA has set a PDUFA target action date for the supplemental New Drug Application (sNDA) to expand the indication of ZORYVE cream to include children aged 2 to 5 years for plaque psoriasis.

: PDUFA

: PDUFA Date

: 86%

: DATROWAY (datopotamab deruxtecan-dlnk) is an antibody-drug conjugate targeting TROP2, developed for patients with unresectable or metastatic triple-negative breast cancer (TNBC) ineligible for PD-1/PD-L1 therapy. The FDA accepted the supplemental Biologics License Application (sBLA) on February 3, 2026, granting it Priority... Show more

: Unresectable or metastatic triple negative breast cancer (TNBC) in patients who are not candidates for PD-1/PD-L1 inhibitor therapy

: Drug: DATROWAY (datopotamab deruxtecan-dlnk). Indication: Unresectable or metastatic triple negative breast cancer (TNBC) in patients who are not candidates for PD-1/PD-L1 inhibitor therapy. Timeline: June 2, 2026. The U.S. sBLA for DATROWAY has been accepted and granted Priority Review; the... Show more

: PDUFA

: PDUFA Date

: 92.5%

: Tebipenem HBr (tebipenem pivoxil hydrobromide, formerly SPR994), developed by Spero Therapeutics (SPRO), is an innovative oral carbapenem antibiotic specifically targeting complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. As the first oral agent in the carbapenem... Show more

: complicated urinary tract infections (cUTI), including pyelonephritis

: Drug: tebipenem HBr. Indication: complicated urinary tract infections (cUTI), including pyelonephritis. Timeline: 2026-06-18. GSK-set PDUFA date for the tebipenem HBr NDA resubmission for cUTI (including pyelonephritis) is June 18, 2026. The NDA is supported by the successful Phase 3 PIVOT-PO... Show more

: PDUFA

: PDUFA Date

: 92.5%

: Olezarsen (TRYNGOLZA), developed by Ionis Pharmaceuticals (IONS), represents a cutting-edge advancement in the treatment of severe hypertriglyceridemia (sHTG). This next-generation N-acetylgalactosamine (GalNAc)-conjugated antisense oligonucleotide is administered as a monthly subcutaneous injection. It specifically targets and degrades hepatic apolipoprotein C-III (apoC-III)... Show more

: severe hypertriglyceridemia (sHTG)

: Drug: olezarsen (TRYNGOLZA). Indication: severe hypertriglyceridemia (sHTG). Timeline: June 30, 2026. FDA accepted the NDA for olezarsen for treatment of severe hypertriglyceridemia and granted Priority Review with a PDUFA target action date of June 30, 2026, per Ionis' Q1 2026... Show more

: PDUFA

: PDUFA Date

: 92.5%

: LNTH-2501 (Ga-68 edotreotide), developed by Lantheus Holdings (LNTH), is a diagnostic kit intended for the preparation of gallium-68 edotreotide injection, specifically designed for positron emission tomography (PET) imaging to localize somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in both adult and... Show more

: somatostatin receptor-positive neuroendocrine tumors (NETs)

: Drug: LNTH-2501 (Ga 68 edotreotide). Indication: somatostatin receptor-positive neuroendocrine tumors (NETs). Timeline: June 29, 2026. The FDA extended the PDUFA date for LNTH-2501, Lantheus' Ga 68 edotreotide PET diagnostic imaging kit for somatostatin receptor-positive neuroendocrine tumors, by three months to... Show more