| CRNX | PALTUSOTINE | 2024-06-30 | PDUFA target action date for NDA review for treatment of acromegaly |
| RCKT | KRESLADI | 2024-12-31 | Rescheduled PDUFA date for NDA review |
| TVTX | FILSPARI | 2025-08-01 | PDUFA date for REMS modification and potential label updates |
| LENZ | LNZ100 | 2025-08-08 | Set PDUFA action date for NDA review for treatment of presbyopia |
| TNXP | TNX-102 SL | 2025-08-15 | Set PDUFA action date for NDA review for treatment of fibromyalgia |
| JAZZ | DORDAVIPRONE | 2025-08-18 | Set PDUFA action date for NDA review for treatment of recurrent H3 K27M-mutant diffuse glioma |
| IONS | DONIDALORSEN | 2025-08-21 | Set PDUFA action date for NDA/BLA review for treatment of hereditary angioedema |
| OTLK | LYTENAVA | 2025-08-27 | Set PDUFA action date for ONS-5010 / LYTENAVA (bevacizumab-vikg) NDA review for treatment of retina diseases |
| OTLK | ONS-5010 | 2025-08-27 | Set PDUFA action date for NDA review |
| TVTX | FILSPARI | 2025-08-28 | PDUFA action date for sNDA to remove embryo-fetal toxicity REMS and modify liver monitoring frequency |
| TVTX | FILSPARI | 2025-08-31 | PDUFA date for REMS modification and potential label updates |
| AGIO | PYRUKYND | 2025-09-07 | Set PDUFA action date for sNDA review for treatment of thalassemia |
| AGIO | PYRUKYND | 2025-09-09 | PDUFA goal date for NDA review for treatment of thalassemia |
| SRRK | APITEGROMAB | 2025-09-22 | Set PDUFA target action date for BLA review |
| IONS | SPINRAZA | 2025-09-22 | Set PDUFA action date for higher dose nusinersen NDA review for treatment of spinal muscular atrophy |
| CRNX | PALSONIFY (PALTUSOTINE) | 2025-09-25 | Set PDUFA action date for NDA review |
| CRNX | PALTUSOTINE | 2025-09-25 | Set PDUFA action date for NDA review for treatment of acromegaly |
| FBIO, FBIOP | CUTX-101 | 2025-09-30 | Set PDUFA action date for NDA review for treatment of Menkes disease |
| FBIO | CUTX-101 | 2025-09-30 | Set PDUFA action date for NDA review for treatment of Menkes disease |
| JAZZ | ZEPZELCA | 2025-10-07 | PDUFA action date for combination with atezolizumab for 1L maintenance treatment of ES-SCLC |
| GKOS | EPIOXA | 2025-10-20 | Set PDUFA action date for NDA review for treatment of keratoconus |
| MRK | WINREVAIR | 2025-10-25 | Set PDUFA action date for sBLA review for label update based on Phase 3 ZENITH trial results |
| ARWR | PLOZASIRAN | 2025-11-18 | Set PDUFA action date for NDA/BLA review |
| KURA | ZIFTOMENIB | 2025-11-30 | Set PDUFA action date for NDA review for treatment of relapsed/refractory NPM1-m AML |
| AXGN | AVANCE NERVE GRAFT | 2025-12-05 | Set PDUFA action date for BLA review following major amendment submission |
| MIST | CARDAMYST | 2025-12-13 | Set PDUFA action date for NDA review of etripamil nasal spray |
| INVA | ZOLIFLODACIN | 2025-12-15 | Set PDUFA action date for NDA review |
| ALDX | REPROXALAP | 2025-12-16 | Set PDUFA action date for NDA review for treatment of dry eye disease |
| CYTK | AFICAMTEN | 2025-12-26 | Set PDUFA action date for NDA review |
| OMER | NARSOPLIMAB | 2025-12-26 | Set action date for BLA review for treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy |
| CORT | RELACORILANT | 2025-12-30 | Set PDUFA action date for NDA review for treatment of hypercortisolism |
| VNDA | TRADIPITANT | 2025-12-30 | Set PDUFA action date for NDA review for treatment of motion sickness |
| HRMY | ZYN002 | 2026-01-01 | PDUFA action date for treatment of Fragile X Syndrome |
| DNLI | TIVIDENOFUSP ALFA | 2026-01-05 | Set PDUFA action date for BLA review for treatment of Hunter syndrome |
| VNDA | HETLIOZ | 2026-01-07 | FDA expedited re-review of sNDA for jet lag disorder treatment |
| ATRA | TAB-CEL | 2026-01-10 | Set PDUFA target action date for BLA review |
| ATRA | TABELECLEUCEL (TAB-CEL) | 2026-01-10 | Set PDUFA action date for BLA review for treatment of EBV+ PTLD |
| TVTX | FILSPARI | 2026-01-13 | Set PDUFA action date for NDA review for treatment of FSGS |
| AQST | ANAPHYLM | 2026-01-31 | Set PDUFA action date for NDA review |
| AQST | LIBERVANT | 2026-01-31 | PDUFA action date for NDA review |
| RGNX | CLEMIDSOGENE LANPARVOVEC (RGX-121) | 2026-02-08 | Extended PDUFA action date for BLA review for treatment of Mucopolysaccharidosis II (Hunter syndrome) |
| VNDA | BYSANTI | 2026-02-21 | Set PDUFA action date for NDA review for treatment of bipolar I disorder and schizophrenia |
| LNTH | PIFLUFOLASTAT F 18 | 2026-03-06 | Set PDUFA action date for NDA review for PSMA PET imaging agent |
| LNTH | F 18 PSMA IMAGING AGENT | 2026-03-06 | Set PDUFA action date for NDA review of new formulation to expand PSMA PET imaging access |
| RCKT, RCKTW | KRESLADI | 2026-03-28 | Set PDUFA action date for BLA review for treatment of severe Leukocyte Adhesion Deficiency-I |
| RCKT | KRESLADI | 2026-03-28 | Set PDUFA action date for BLA review for treatment of severe Leukocyte Adhesion Deficiency-I |
| DNLI | TIVIDENOFUSP ALFA | 2026-04-05 | Rescheduled PDUFA action date for BLA review for treatment of Hunter syndrome (MPS II) |
| REPL | RP1 | 2026-04-10 | Set PDUFA action date for BLA review in combination with nivolumab for advanced melanoma |
| GRCE | GTX-104 | 2026-04-23 | Set PDUFA action date for NDA review for treatment of aneurysmal subarachnoid hemorrhage |
| MRK | DORAVIRINE/ISLATRAVIR | 2026-04-28 | Set PDUFA action date for NDA review for treatment of HIV-1 |
| MRK | MK-8591A | 2026-04-28 | Set PDUFA action date for NDA review for treatment of adults with virologically suppressed HIV-1 |
| CING, CINGW | CTX-1301 | 2026-05-31 | Set PDUFA action date for NDA review for treatment of ADHD |
| CING | CTX-1301 | 2026-05-31 | Set PDUFA action date for NDA review for treatment of ADHD |
| ARVN | VEPDEGESTRANT | 2026-06-05 | Set action date for NDA review for treatment of ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer |
| CORT | RELACORILANT | 2026-07-11 | Set PDUFA action date for NDA review for treatment of platinum-resistant ovarian cancer |
| HRMY | ZYN002 | 2026-12-31 | PDUFA action date for treatment of Fragile X Syndrome |