Bristol-Myers, Acceleron: FDA Drops Planned Panel Review of Reblozyl
December 06 2019 - 12:45PM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. (BMY) and Acceleron Pharma Inc. (XLRN)
Friday said the U.S. Food and Drug Administration has reversed
course on a planned advisory committee review of the use of the
anemia drug Reblozyl in patients with myelodysplastic
syndromes.
The companies said the change follows a late-cycle review
meeting on Wednesday, adding that the target action date for the
supplemental biologics license application remains April 4,
2020.
Bristol-Myers and Acceleron on Tuesday had said that the FDA's
advisory panel on oncologic drugs would review the sBLA at its
meeting on Dec. 18.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 06, 2019 12:30 ET (17:30 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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