Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
Bristol Myers Squibb: Opdivo sBLA PDUFA ditetapkan pada 8 April 2026
FDA memberikan tinjauan prioritas dan menetapkan tanggal target PDUFA 8 April 2026 untuk sBLA Opdivo plus doxorubicin, vinblastine dan dacarbazine pada Limfoma Hodgkin klasik Stadium III atau IV yang belum diobati sebelumnya. EMA juga memvalidasi aplikasi variasi Tipe II yang sesuai, memulai tinjauan terpusat.
Fakta utama
- Diajukan
- 5 Feb 2026, 12.07
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
BMYBristol-Myers Squibb- Aset
- nivolumab
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 8 Apr 2026 · Hasil belum tercatat
Kutipan sumber
EX-99.1 2 a2025q4ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED FEBRUARY 5, 2026 Document Exhibit 99.1 Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2025 Financial results reflect disciplined execution and focus on delivering long-term growth • Fourth quarter revenues increased 1% to $12.5 billion; Growth Portfolio revenues increased 16% to $7.4 billion ◦ GAAP EPS was $0.53 and non-GAAP EPS was $1.26; Both figures include net impact of $(0.60) due to the Acquired IPRD charges and licensing income • Full-year revenues were $48.2 billion; Growth Portfolio revenues increased 17% to $26.4 billion ◦ GAAP EPS was $3.46 and non-GAAP EPS was $6.15; Both figures include net impact of $(1.40) due to the Acquired IPRD charges and licensing income •