Catatan sumber primer
PenentuPersetujuan FDA
Merck menerima persetujuan FDA untuk IDVYNSO pada HIV-1 yang ditekan secara virologis
Dokumen menyatakan bahwa Merck menerima persetujuan FDA AS untuk IDVYNSO, pengobatan oral sekali sehari untuk orang dewasa tertentu dengan HIV-1 yang ditekan secara virologis. Persetujuan ini menandai tonggak regulasi baru bagi lini HIV Merck dan memperluas portofolio yang disetujui di bidang penyakit infeksi. Persetujuan disajikan sebagai hasil regulasi yang telah selesai tanpa tanggal PDUFA atau komite penasihat lebih lanjut yang disebutkan.
Fakta utama
- Diajukan
- 30 Apr 2026, 10.53
- Peristiwa
- Persetujuan FDA
- Arah
- Positif
- Perusahaan
MRKMSD- Aset
- IDVYNSO
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- participants 65 plus
- 81 (11%)
- participants 75 plus
- 10 (1%)
- trial 051 suppression
- 96% vs 92%
- trial 052 suppression
- 92% vs 94%
- trial 051 hiv rna ge 50
- 1% vs 5% (IDVYNSO vs bART)
- trial 052 hiv rna ge 50
- 1% vs 1% (IDVYNSO vs BIC/FTC/TAF)
Kutipan sumber
EX-99.1 2 tm2612241d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 News Release Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches - Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX) o KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million o WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX) o Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX) - GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Ch