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RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administer...

SHANGHAI e JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK), e Organon (NYSE: OGN) oggi hanno annunciato che la Commissione europea (CE) ha concesso l'autorizzazione all'immissione in commercio di BILDYOS® (denosumab) soluzione iniettabile da 60 mg/ml e BILPREVDA® (denosumab) soluzione iniettabile da 120 mg/1,7 ml, biosimilari rispettivamente di PROLIA (denosumab) e XGEVA (denosumab), per tutte le indicazioni dei prodotti di riferimento.1,2 “Le autorizzazioni di BILD...

SHANGHAI & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696, HK) en Organon (NYSE: OGN) hebben vandaag aangekondigd dat de Europese Commissie (EC) een handelsvergunning heeft verleend voor BILDYOS® (denosumab)-injectie 60 mg/ml en BILPREVDA® (denosumab)-injectie 120 mg/1,7 ml, biosimilars van respectievelijk PROLIA (denosumab) en XGEVA (denosumab), voor alle indicaties van de referentieproducten.1,2 "De goedkeuringen door de EC van BILDYOS en BILPREVDA markeren een cruci...

SHANGHAI et JERSEY CITY, New Jersey--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) et Organon (NYSE : OGN) ont annoncé aujourd’hui que la Commission européenne (CE) avait accordé une autorisation de mise sur le marché pour BILDYOS® (denosumab) injection 60 mg/mL et BILPREVDA® (denosumab) injection 120 mg/1,7 mL, biosimilaires de PROLIA (denosumab) et XGEVA (denosumab), respectivement, pour toutes les indications des produits de référence.1,2 « Les autorisations de mise sur le marché...

SHANGHAI y JERSEY CITY, Nueva Jersey--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) y Organon (NYSE: OGN) acaban de anunciar que la Comisión Europea (CE) ha autorizado la comercialización de BILDYOS® (denosumab) inyectable 60 mg/ml y BILPREVDA® (denosumab) inyectable 120 mg/1,7 ml, biosimilares de PROLIA (denosumab) y XGEVA (denosumab), respectivamente, para todas las indicaciones de los productos de referencia.1,2 «Las aprobaciones de la CE de BILDYOS y BILPREVDA suponen un hito cr...

SHANGHAI UND JERSEY CITY, NEW JERSEY--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) und Organon (NYSE: OGN) gaben heute die Erteilung der Marktzulassung durch die Europäische Kommission (EK) für die BILDYOS® (Denosumab)-Injektion 60 mg/ml und die BILPREVDA® (Denosumab)-Injektion 120 mg/1,7 ml bekannt, Biosimilars zu PROLIA (Denosumab) bzw. XGEVA (Denosumab. Diese Zulassung gilt für alle Indikationen der Referenzprodukte.1,2 „Die Zulassung von BILDYOS und BILPREVDA durch die EK ist e...

MINNEAPOLIS--(BUSINESS WIRE)--A study by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) found that a donor search prognosis-based strategy helps physicians move patients with blood cancers and other blood diseases to hematopoietic cell transplant (HCT) faster, resulting in similar transplant success regardless of likelihood of finding a matched unrelated donor (MUD). Investigators from the consortium of U.S. transplant centers, CIBMTR® (Center for International Blood and Marr...

WAKEFIELD, Mass.--(BUSINESS WIRE)--Virtual, Inc. continues longstanding support for cancer research as a major sponsor of Jimmy Fund Day at Fenway on Sept 20....

NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IBTROZITM (taletrectinib) for the treatment of adult patients with ROS1-positive (ROS1+) unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC). As part of an exclusive license agreement entered in 2023, Nippon Kayaku will commercial...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for KEYTRUDA® (pembrolizumab), which if approved would be marketed in...