Record mula sa primary source
Decision-gradeUpdate sa FDA label
Regeneron: Inaprubahan ng FDA ang EYLEA HD para sa RVO at kakayahang umangkop sa buwanang dosis
Inaprubahan ng FDA ang EYLEA HD para sa macular edema kasunod ng RVO at para sa buwanang dosis sa lahat ng aprubadong indikasyon. Isang bagong tagagawa ang naaprubahan din para punan ang mga vial ng EYLEA HD, at isang aplikasyon sa regulasyon para sa parehong tagagawa na punan ang mga pre-filled syringe ay may inaasahang desisyon sa Q2 2026.
Mahahalagang fact
- Na-file
- Ene 30, 2026, 11:51 AM
- Kaganapan
- Update sa FDA label
- Direksyon
- Positibo
- Kumpanya
REGNRegeneron- Asset
- aflibercept
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 exhibit991q42025.htm EXHIBIT 99.1 Document Exhibit 99.1 Press Release Regeneron Reports Fourth Quarter and Full Year 2025 Financial and Operating Results • Fourth quarter 2025 revenues increased 3% to $3.9 billion versus fourth quarter 2024; full year 2025 revenues increased 1% to $14.3 billion versus 2024 • Fourth quarter 2025 Dupixent ® global net sales (recorded by Sanofi) increased 34% to $4.9 billion versus fourth quarter 2024; full year 2025 Dupixent global net sales increased 26% to $17.8 billion versus 2024 • Fourth quarter 2025 EYLEA HD ® U.S. net sales increased 66% to $506 million and total EYLEA HD and EYLEA ® U.S. net sales decreased 28% to $1.1 billion; full year 2025 EYLEA HD U.S. net sales increased 36% to $1.6 billion and total EYLEA HD and EYLEA U.S. net sal