Bristol Myers (BMY) Gets FDA Nod for Breyanzi Label Expansion [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
Last bristol-myers squibb company earnings: 2/6 07:05 am
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Source: Yahoo! Finance
The regulatory body approved Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Breyanzi is already approved in the United Stated for treating relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy. The therapy was also granted accelerated approval to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy. Breyanzi is also approved in Japan, the European Union (EU) and Switzerland for the second-line treatment or relapsed or refractory LBCL, and in Japan, the EU, Switzerland, the U.K. and Canada for relapsed and refractory
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BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 5/9/24 - Form 8-K
- 5/3/24 - Form 4
- 4/25/24 - Form 10-Q
- BMY's page on the SEC website