Record mula sa primary source
MateryalTinanggap ang aplikasyon
Tinanggap ang sBLA ng Breyanzi na may PDUFA noong Disyembre 5, 2025 para sa r/r marginal zone lymphoma
Tinanggap ng FDA ang supplemental BLA para sa Breyanzi sa relapsed/refractory marginal zone lymphoma (≥2 prior lines) at binigyan ito ng Priority Review. Nagtakda ang ahensya ng PDUFA goal date na Disyembre 5, 2025, na nagbibigay ng malapit na regulatory decision point para sa bagong indikasyong ito.
Mahahalagang fact
- Na-file
- Okt 30, 2025, 11:09 AM
- Kaganapan
- Tinanggap ang aplikasyon
- Direksyon
- Positibo
- Kumpanya
BMYBristol-Myers Squibb- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Dis 5, 2025 · Walang naitalang resulta
Sipi mula sa source
EX-99.1 2 a2025q3ex991.htm PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED OCTOBER 30, 2025 Document Exhibit 99.1 Bristol Myers Squibb Reports Third Quarter Financial Results for 2025 Performance Marked by Continued Growth Portfolio Momentum, Pipeline Advancements and Strategic Business Development • Third quarter revenues increased 3% (+2% Ex-FX) to $12.2 billion ◦ Growth Portfolio revenues increased 18% (+17% Ex-FX) to $6.9 billion • GAAP EPS was $1.08 and non-GAAP EPS was $1.63; Both figures include net impact of $(0.20) due to the Acquired IPRD charges and licensing income • Raising 2025 revenue guidance to a range of ~$47.5 billion to $48.0 billion; Updating non-GAAP EPS range to $6.40 to $6.60, inclusive of an $(0.80) per share net impact from Acquired IPRD charges and licensi