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Cycle Pharmaceuticals’ HARLIKU™ (nitisinone) Tablets Receive First FDA-Approval as Treatment for Alkaptonuria (AKU)

BOSTON & CAMBRIDGE, England--(BUSINESS WIRE)--Cycle Pharmaceuticals announced that the FDA has approved HARLIKU (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU.1 Launching in July 2025, HARLIKU will be the first and only FDA-approved treatment for AKU,1 an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys, and heart.2 Patients with AKU often d...
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Cube Click, Inc. Secures FDA Approval for SMILE Dx—A Game-Changer in Dental AI Diagnostics

NEW YORK--(BUSINESS WIRE)--FDA APPROVES SMILE Dx....
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Newly Published Health Economics Study Demonstrates In-Office Ear Tube Procedures with Hummingbird TTS Significantly Reduce Healthcare Costs

GOLDEN VALLEY, Minn.--(BUSINESS WIRE)--Preceptis Medical, Inc., a pioneer in pediatric ENT innovation, today announced the publication of a health economic study assessing the financial impact of shifting pediatric tympanostomy tube (ear tube) placement from operating room to in-office settings. The analysis, published in the Journal of Medical Economics, demonstrates significant cost savings potential for Commercial and Medicaid health insurance payers that provide access to in-office ear tube...
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Incyte annonce l’autorisation de Monjuvi® (tafasitamab-cxix) par la FDA en combinaison avec rituximab et lénalidomide pour les patients souffrant de lymphome folliculaire en rechute ou réfractaire

WILMINGTON, Delaware--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) a annoncé aujourd’hui que la Food and Drug Administration (FDA) des États-Unis a autorisé Monjuvi® (tafasitamab-cxix), un anticorps monoclonal humanisé ciblant la protéine CD19 cytolytique modifiée Fc, en combinaison avec rituximab et lénalidomide pour le traitement des patients adultes atteints d’un lymphome folliculaire en rechute ou réfractaire. « Les patients souffrant d’un lymphome folliculaire en rechute ou réfractaire attendent...
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Incyte gibt FDA-Zulassung für Monjuvi® (Tafasitamab-cxix) in Kombination mit Rituximab und Lenalidomid für Patienten mit rezidiviertem oder refraktärem follikulärem Lymphom bekannt

WILMINGTON, Delaware--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) gab heute bekannt, dass die US-amerikanische Arzneimittelbehörde (FDA) die Zulassung für Monjuvi® (Tafasitamab-cxix), einen humanisierten Fc-modifizierten zytolytischen CD19-gerichteten monoklonalen Antikörper, in Kombination mit Rituximab und Lenalidomid für die Behandlung von erwachsenen Patienten mit rezidiviertem oder refraktärem follikulärem Lymphom (FL) erteilt hat. „Patienten mit rezidiviertem oder refraktärem FL warten seit lan...
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Resumen: Incyte anuncia la aprobación de Monjuvi® (tafasitamab-cxix) por parte de la FDA en combinación con rituximab y lenalidomida para tratar pacientes con linfoma folicular recidivante o refractario

WILMINGTON, Delaware.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) ha anunciado hoy que la Administración de Alimentos y Medicamentos de Estados Unidos (FDA) ha aprobado Monjuvi® (tafasitamab-cxix), un anticuerpo monoclonal citolítico humanizado y modificado con Fc dirigido contra el CD19, en combinación con rituximab y lenalidomida para tratar pacientes adultos con linfoma folicular recidivante o refractario (LF). El comunicado en el idioma original es la versión oficial y autorizada del mismo. Esta...
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Samenvatting: Incyte maakt FDA-goedkeuring bekend voor Monjuvi® (tafasitamab-cxix) in combinatie met rituximab en lenalidomide voor patiënten met recidiverend of refractair folliculair lymfoom

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) maakte vandaag bekend dat de Amerikaanse FDA (U.S. Food & Drug Administration) Monjuvi® (tafasitamab-cxix), een gehumaniseerd Fc-gemodificeerd cytolytisch CD19-gericht monoklonaal antilichaam, in combinatie met rituximab en lenalidomide heeft goedgekeurd voor de behandeling van volwassen patiënten met recidiverend of refractair folliculair lymfoom (FL). Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn s...
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Riassunto: Incyte annuncia l'approvazione dell'FDA di Monjuvi® (tafasitamab-cxix) in combinazione con rituximab e lenalidomide per i pazienti affetti da linfoma follicolare recidivante o refrattario

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) oggi ha annunciato che la Food and Drug Administration (FDA) statunitense ha approvato Monjuvi® (tafasitamab-cxix), un anticorpo monoclonale umanizzato Fc-modificato citolitico CD19 avente come bersaglio il CD19, in combinazione con rituximab e lenalidomide per il trattamento di pazienti adulti con linfoma follicolare (LF) recidivante o refrattario. Il testo originale del presente annuncio, redatto nella lingua di partenza, è la versione u...
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AHF: Gilead’s Greed Kills Promise of Lenacapavir for HIV Prevention

LOS ANGELES--(BUSINESS WIRE)--AHF: Gilead’s Greed Kills Promise of Lenacapavir for HIV Prevention...
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Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). "Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without...