Catatan sumber primer
PenentuPersetujuan FDA
Merck menerima persetujuan FDA untuk injeksi subkutan KEYTRUDA QLEX
Dokumen menyatakan bahwa Merck menerima persetujuan FDA untuk KEYTRUDA QLEX Injection untuk penggunaan subkutan pada semua indikasi tumor padat untuk KEYTRUDA. Hal ini mengubah formulasi biologik intravena yang ada menjadi formulasi subkutan, memperluas opsi pengiriman untuk aset yang sama tanpa mengubah indikasi yang disetujui.
Fakta utama
- Diajukan
- 30 Okt 2025, 10.40
- Peristiwa
- Persetujuan FDA
- Arah
- Positif
- Perusahaan
MRKMSD- Aset
- pembrolizumab
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- N
- 1841
- p
- 0.0003
- CI
- 0.59-0.87
- HR
- 0.72
- 24mo DFS
- 81% vs 74%
Kutipan sumber
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
