Record mula sa primary source
Decision-gradePag-apruba ng FDA
Nakatanggap ang Merck ng pag-apruba ng FDA para sa subcutaneous injection ng KEYTRUDA QLEX
Nakasaad sa dokumento na nakatanggap ang Merck ng pag-apruba ng FDA para sa KEYTRUDA QLEX Injection para sa subcutaneous use sa lahat ng solid tumor indications para sa KEYTRUDA. Ito ay nagko-convert ng isang existing intravenous biologic sa isang subcutaneous formulation, na nagpapalawak ng mga delivery options para sa parehong asset nang hindi binabago ang mga approved indications.
Mahahalagang fact
- Na-file
- Okt 30, 2025, 10:40 AM
- Kaganapan
- Pag-apruba ng FDA
- Direksyon
- Positibo
- Kumpanya
MRKMSD- Asset
- pembrolizumab
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- N
- 1841
- p
- 0.0003
- CI
- 0.59-0.87
- HR
- 0.72
- 24mo DFS
- 81% vs 74%
Sipi mula sa 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
