Record mula sa primary source
Decision-gradePag-apruba ng FDA
Nakatanggap ang Merck ng pag-apruba mula sa FDA para sa IDVYNSO sa HIV-1 na virologically suppressed
Nakasaad sa dokumento na nakatanggap ang Merck ng pag-apruba mula sa U.S. FDA para sa IDVYNSO, isang oral treatment na isang beses sa isang araw para sa ilang mga nasa hustong gulang na may virologically suppressed HIV-1. Ang pag-aprubang ito ay nagmamarka ng bagong regulatory milestone para sa HIV franchise ng Merck at nagpapalawak ng kanilang aprubadong portfolio sa infectious diseases. Ang pag-apruba ay ipinakita bilang isang completed regulatory outcome na walang karagdagang PDUFA o advisory-committee dates na binanggit.
Mahahalagang fact
- Na-file
- Abr 30, 2026, 10:53 AM
- Kaganapan
- Pag-apruba ng FDA
- Direksyon
- Positibo
- Kumpanya
MRKMSD- Asset
- IDVYNSO
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- 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)
Sipi mula sa source
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
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Decision-grade
Abr 20, 2026
12:00 AM
MRKMSD