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Journal of Psychiatric Research, 70 , 50-57

BLA accepted 8.23.2026DTX401 (pariglasgene brecaparvovec)Glycogen storage disease type 1a (GSD1a)UltragenyxBLA accepted 8.25.2026DasynocChronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL)Xspray PharmaNDA accepted 8.28.2026177Lu-edotreotideGastroenteropancreatic neuroendocrine tumorsITMNDA accepted 8.30.2026Besremi (ropeginterferon alfa-2b-njft)Essential thrombocythemiaPharmaEssentia USA CorporationsBLA accepted 9.18.2026ZidesamtinibROS1-positive non-small cell lung cancerNuvalentNDA accepted 9.19.2026UX111 (rebisufligene etisparvovec)Sanfilippo syndrome Type A (MPS IIIA)UltragenyxBLA accepted 9.19.2026Aqneursa (levacetylleucine)Ataxia-telangiectasiaIntraBiosNDA accepted 9.22.2026ZilganersenAlexander diseaseIonis PharmaceuticalsNDA accepted 9.26.2026ZilurgisertibFibrodysplasia ossificans progressivaMirumNDA accepted 9.27.2026LirafugratinibCholangiocarcinomaElevar TherapeuticsNDA accepted 9.28.2026Emcitate (tiratricol)MCT8 deficiencyEgetis TherapeuticsNDA accepted 9.30.2026ApitegromabSpinal muscular atrophy (SMA)ScholarRockBLA accepted 9.30.2026Camzyos (mavacamten)Obstructive hypertrophic cardiomyopathy (oHCM)Bristol Myers SquibbsNDA accepted September 2026BrepocitinibDermatomyositisPriovant TherapeuticsNDA accepted Q4 2026IvonescimabEGFR-mutated NSCLCSummit TherapeuticsBLA submitted 10.10.2026TabelecleucelEpstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD)Pierre Fabre PharmaceuticalsBLA accepted 10.30.2026INO-3107Recurrent respiratory papillomatosis (RRP)INOVIOBLA accepted 11.17.2026AdrabetadexNiemann-Pick type CBeren TherapeuticsNDA accepted 11.22.2026MolbreeviAutoimmune pulmonary alveolar proteinosis (autoimmune PAP)Savara BLA accepted 11.2026Zeleciment rostudirsenDuchenne muscular dystrophyDyne TherapeuticsBLA accepted 11.25.2026VenglustatType 3 Gaucher diseaseSanofiNDA accepted 11.27.2026BBP-418Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)BridgeBioNDA accepted 11.27.2026SaroglitazarPrimary biliary cholangitisZydus TherapeuticsNDA accepted 11.30.2026PovetaciceptIgA nephropathyVertex PharmaceuticalsBLA accepted 12.12.2026ImsidolimabGeneralized pustular psoriasis (GPP)Vanda PharmaceuticalsBLA accepted 12.18.2026TirabrutinibR/R primary central nervous system lymphoma (PCNSL)Deciphera PharmaceuticalsNDA accepted 12.23.2026Anito-celR/R multiple myelomaGileadBLA accepted 12.27.2026RelutrigineSCN2A and SCN8A DEEsPraxisNDA accepted 12.30.26BezuclastinibNonadvanced systemic mastocytosisCogent BiosciencesNDA accepted Q4 2026EncaleretAutosomal dominant hypocalcemia type 1 (ADH1)BridgeBioNDA accepted Q4 2026Ultomiris (ravulizumab)Immunoglobulin A nephropathy (IgAN)AstraZenecasBLA accepted 1.21.2027Zeleciment rostudirsenDuchenne muscular dystrophyDyne TherapeuticsBLA accepted 2.28.2027Amondys 45 (casimersen) and Vyondys 53 (golodirsen)Duchenne muscular dystrophySarepta TherapeuticssNDA accepted 2.28.2027Voxzogo (vosoritide)AchondroplasiaBioMarinsNDA accepted 4.23.2027DeucrictibantHereditary angioedemaPharvaris NDA accepted 4.28.2027VaregacestatDesmoid tumorsImmunomeNDA accepted 5.1.2027AXS-12 (reboxetine)NarcolepsyAxsome TherapeuticsNDA accepted 5.8.2027EncaleretAutosomal dominant hypocalcemia type 1 (ADH1)BridgeBio PharmaNDA accepted 5.13.2027MezigdomideMultiple myelomaBristol Myers Squibb NDA accepted 2025 Orphan Drugs: PDUFA Dates and FDA Approvals 2024 Orphan Drugs: PDUFA Dates and FDA Approvals 2023 Orphan Drugs: PDUFA Dates and FDA Approvals 2022 Orphan Drugs: PDUFA Dates and FDA Approvals 2021 Orphan Drugs: PDUFA Dates and FDA Approvals Related ArticlesFDA Approves Onivyde Combination for MetastaticFDA Approves Eohilia for Eosinophilic EsophagitisFDA Approves First CAR T-Cell Therapy for AdultsFDA Approves First-In-Class Treatment For PulmonaryFDA Approves Ultomiris for Treatment ofFDA Approves Winrevair for Pulmonary Arterial

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Life Sciences , 54 (5), PL63PL68

Supporting telomere maintenance and circadian rhythm regulation may promote improved rest and overall vitality for body and mind