The U.S. Food and Drug Administration is speeding up its review of an oral medicine for sickle cell disease that may fill a ...
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ...
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AGIO's filing for mitapivat in SCD gets FDA's priority tag, stock up
Agios Pharmaceuticals AGIO announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval ...
Global Blood Therapeutics Inc (NASDAQ: GBT) has submitted a supplemental marketing application to the FDA seeking accelerated approval for Oxbryta (voxelotor) for the treatment of Sickle Cell Disease ...
SAN FRANCISCO, Dec. 12, 2024 /PRNewswire/ -- Kind Pharmaceutical ("Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC"), a clinical-stage biopharmaceutical company focused on developing ...
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ...
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