Merck reçoit l'approbation de la FDA pour l'injection sous-cutanée KEYTRUDA QLEX

Le document indique que Merck a reçu l'approbation de la FDA pour KEYTRUDA QLEX Injection pour une utilisation sous-cutanée dans toutes les indications de tumeurs solides pour KEYTRUDA. Cela convertit un produit biologique intraveineux existant en une formulation sous-cutanée, élargissant les options d'administration pour le même actif sans modifier les indications approuvées.

Faits clés

Déposé: 30 oct. 2025, 10:40
Événement: Approbation FDA
Direction: Positif
Société: MRKMSD
Actif: pembrolizumab
Source: SEC 8-K
Fiabilité: Sourcé
N: 1841
p: 0.0003
CI: 0.59-0.87
HR: 0.72
24mo DFS: 81% vs 74%

Extrait de la source

EX-99.1 2 tm2529620d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 - 1 - News Release Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2025 Financial Results - Total Worldwide Sales Were $17.3 Billion, an Increase of 4% From Third Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 3% o KEYTRUDA Sales Grew 10% to $8.1 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 8% o WINREVAIR Sales Were $360 Million; Growth of 141% Both Nominally and Excluding the Impact of Foreign Exchange o CAPVAXIVE Sales Were $244 Million o GARDASIL/GARDASIL 9 Sales Declined 24% to $1.7 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 25% o Animal Health Sales Grew 9% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 7% - GAAP EPS Was

SEC 8-K