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PDUFA DateOrphan DrugIndicationCompanyStatus 1.5.2026Cablivi (caplacizumab)Acquired thrombotic thrombocytopenic purpura (aTTP)SanofiAPPROVED 1.10.2026TabelecleucelEpstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD)Atara BiotherapeuticsComplete Response Letter 1.13.2026Cerezyme (imiglucerase)Gaucher disease type 3SanofiAPPROVED 1.14.2026Copper histidinate (CUTX-101)Menkes diseaseSentynl TherapeuticsAPPROVED 1.27.2026Darzalex Faspro with D-VRdMultiple myelomaJohnson & JohnsonAPPROVED 1.31.2026LeniolisibActivated phosphoinositide 3-kinase delta syndrome (APDS)Pharming GroupComplete Response Letter 2.8.2026Clemidsogene lanparvovec (RGX-121)Mucopolysaccharidosis II (MPS II)REGENXBIOComplete Response Letter 2.13.2026BitopertinErythropoietic protoporphyria (EPP)Disc MedicineComplete Response Letter 2.20.2026Venetoclax plus acalabrutinibChronic lymphocytic leukemiaAbbVieAPPROVED 2.23.2026PegzilarginaseArginase 1 deficiency (ARG1-D)Immedica Pharma ABAPPROVED 2.25.2026Inqovi (decitabine and cedazuridine) plus Venclexta (venetoclax)Acute myeloid leukemiaTaiho OncologysNDA accepted 2.25.2026ET-600Arginine vasopressin deficiency (AVP-D)Eton PharmaceuticalsAPPROVED 2.28.2026Palynziq (pegvaliase)Phenylketonuria (PKU)BioMarin APPROVED 2.28.2026TransCon CNP (navepegritide)AchondroplasiaAscendis PharmaAPPROVED 2.28.2026IdebenoneLeber hereditary optic neuropathy (LHON)ChiesiComplete Response Letter 3.5.2026Tec-Dara [Tecvayli(teclistamab) plus Darzalex Faspro (daratumumab and hyaluronidase)]Multiple myelomaJohnson & JohnsonAPPROVED 3.3.2026Juxtapid (lomitapide)Homozygous familial hypercholesterolemia (HoFH)ChiesiAPPROVED 3.10.2026Wellcovorin (leucovorin calcium)Cerebral folate deficiencyGSKAPPROVED 3.24.2026LinerixibatPrimary biliary cholangitis AlfasigmaAPPROVED 3.28.2026Kresladi (marnetegragene autotemcel)Leukocyte adhesion deficiency-I (LAD-I)Rocket PharmaceuticalsAPPROVED 4.2.2026Tecartus (brexucabtagene autoleucel)Mantle cell lymphomaGilead/Kite OncologyAPPROVED 4.3.2026Nusinersen high-dose regimenSpinal muscular atrophyBiogenAPPROVED 4.5.2026Tividenofusp alfaHunter syndrome (MPS II)Denali TherapeuticsAPPROVED 4.8.2026Opdivo (nivolumab)Stage III or IV classical Hodgkin Lymphoma (cHL)Bristol Myers SquibAPPROVED 4.13.2026FILSPARI (sparsentan)Focal segmental glomerulosclerosis (FSGS)Travere TherapeuticsAPPROVED 4.23.2026Otarmeni (lunsotogene parvec-cwha)OTOF-related hearing lossRegeneron PharmaceuticalsAPPROVED 5.1.2026Jakafi XR (ruxolitinib)Myelofibrosis, polycythemia vera, and graft-versus-host diseaseIncyteAPPROVED 5.10.2026Vyvgart (efgartigimod alfa-fcab)AChR-Ab seronegative generalized myasthenia gravis (gMG)ArgenxAPPROVED 5.27.2026Pivekimab sunirineBlastic plasmacytoid dendritic cell neoplasm (BPDCN)AbbVieAPPROVED 6.2.2026Cavhanza (nilotinib)Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) Cycle PharmaAPPROVED 6.10.2026Oclaiz (CAM2029)AcromegalyCamurusComplete Response Letter 6.18.2026XS003 (nilotinib)Chronic myeloid leukemia (CML)Xspray PharmaComplete Response Letter 6.29.2026LNTH-2501 (Gallium-68 edotreotide)Somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs)Lantheus HoldingsComplete Response Letter 6.30.2026VeligrotugThyroid eye disaseViridian TherapeuticsAPPROVED Q3 2026RusfertidePolycythemia vera (PV)Takeda and Protagonist TherapeuticsNDA accepeted 7.6.2026Tregzi (Orca-T)Acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromesOrca BioAPPROVED 7.7.2026AtaciceptIgA NephropathyVera TherapeuticsAPPROVED 7.23.2026SarclisaMultiple MyelomaSanofiAPPROVED 8.17.2026IberdomideMultiple MyelomaBristol Myers SquibNDA accepted 8.22.2026DeramiocelDuchenne muscular dystrophyCapricor TherapeuticsCRL lifted

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