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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...

HYOGO, Japan--(BUSINESS WIRE)--JCR announced that is has achieved a key research milestone in one of its collaborative programs with Alexion, AstraZeneca Rare Disease....

LAWRENCE, Kan.--(BUSINESS WIRE)--Endpoints News Announces the 2025 Winners of the Endpoints 11 Awards, Highlighting Biotech’s Most Promising Startups...

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma: Late-Breaking Data at EADV 2025 Showing Week 16 Tralokinumab Response Predicts Long-Term Response in Moderate-to-Severe Atopic Dermatitis...

KYOTO & FUJISAWA, Japan--(BUSINESS WIRE)--xFOREST Therapeutics Co., Ltd. (“xFOREST”) and Axcelead Drug Discovery Partners, Inc. (“Axcelead DDP”) today announced the launch of a joint research collaboration aimed at developing RNA structure-targeted small molecule therapeutics for multiple diseases. xFOREST has developed a proprietary drug discovery platform, “FOREST Technologies,” which integrates a custom-designed RNA structure library and high-throughput screening technology. The platform spe...