Business Wire

bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with 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 ...
Yahoo Finance

Global Blood Submits US Application For Expanded Use Of SCD Drug, Oxbryta, In Patients Aged 4-11 Years

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 ...
Seeking Alpha

SeaStar Medical Projects Multibillion-Dollar Market Potential for its Selective Cytopheretic Device in Initial Target Indications

“The estimated size of these U.S. markets versus our projected clinical trial costs clearly warrant pursuing FDA approvals in these indications. The ability to use the SCD as currently configured, ...
Business Wire

bluebird bio Announces FDA Priority Review of the Biologics License Application for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years ...

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 ...