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Record mula sa primary source

MateryalNaitakda ang petsa ng PDUFA

Bristol Myers Squibb: Opdivo sBLA PDUFA itinakda sa Abril 8, 2026

Nagbigay ang FDA ng priority review at nagtalaga ng PDUFA goal date na Abril 8, 2026 para sa sBLA ng Opdivo kasama ang doxorubicin, vinblastine at dacarbazine sa mga hindi pa nagamot na Stage III o IV classical Hodgkin Lymphoma. Pinatunayan din ng EMA ang kaukulang Type II variation application, na nagpasimula ng centralized review.

Mahahalagang fact

Na-file
Peb 5, 2026, 12:07 PM
Kaganapan
Naitakda ang petsa ng PDUFA
Direksyon
Neutral
Kumpanya
BMYBristol-Myers Squibb
Asset
nivolumab
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · Abr 8, 2026 · Walang naitalang resulta

Sipi mula sa source

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 •

SEC 8-K

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