Bristol-Myers, Acceleron: FDA Panel to Review Reblozyl in Myelodysplastic Syndromes

Date : 04/12/2019 @ 00:35
Source : Dow Jones News
Stock : Bristol Myers Squibb Co (BMY)
Quote : 59.48  0.58 (0.98%) @ 09:27
Bristol Myers Squibb share price Chart
After Hours
Last Trade
Last $ 59.51 ▲ 0.03 (0.05%)

Bristol-Myers, Acceleron: FDA Panel to Review Reblozyl in Myelodysplastic Syndromes

Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart

1 Month : From Nov 2019 to Dec 2019

Click Here for more Bristol Myers Squibb Charts.

By Colin Kellaher

 

Bristol-Myers Squibb Co. (BMY) and Acceleron Pharma Inc. (XLRN) on Tuesday said a U.S. Food and Drug Administration advisory committee will review the use of the anemia drug Reblozyl in patients with myelodysplastic syndromes.

The companies said the FDA's advisory panel on oncologic drugs will review Bristol-Myers' supplemental biologics license application for Reblozyl at its meeting on Dec. 18.

Celgene Corp., which Bristol-Myers recently acquired, filed with the FDA in April seeking approval of Reblozyl for adults with anemia related to very low to intermediate risk myelodysplastic syndromes with ring sideroblasts who require red blood cell transfusions, as well as adults with anemia related to beta-thalassemia-associated anemia who require red blood cell transfusions.

The agency set a target action date of April 4, 2020, for the indication in patients with myelodysplastic syndromes and recently approved the drug for adults with beta thalassemia under a priority-review designation.

Celgene and Acceleron, a Cambridge, Mass., biopharmaceutical company, are co-developing Reblozyl under a collaboration they formed in 2011.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

December 03, 2019 08:20 ET (13:20 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
Your Recent History
FX
EURAUD
Euro vs Au..
FX
USDAUD
US Dollar ..
ASX
WPL
Woodside
NASDAQ
AAPL
Apple
ASX
BHP
BHP Bilito..
Stocks you've viewed will appear in this box, letting you easily return to quotes you've seen previously.

Register now to create your own custom streaming stock watchlist.

NYSE, AMEX, and ASX quotes are delayed by at least 20 minutes.
All other quotes are delayed by at least 15 minutes unless otherwise stated.

By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions

P: V:au D:20191205 22:47:56