Tag: Biologics License Application
April 5, 2019
Celgene and Acceleration Pharma Announce Submission of Luspatercept Biologics License Application to FDA
Celgene (NASDAQ:CELG) and Acceleron Pharma (NASDAQ:XLRN) have announced that Celegene has submitted a biologics license application for luspatercept, which is... December 20, 2018
DBV Technologies Provides Update on Viaskin Peanut for Children Four to 11 Years of Age
DBV Technologies (Nasdaq:DBVT) announced that after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA)... November 15, 2018
NewLink Genetics Announces Merck Has Begun Rolling Submission of Licensure Application for Ebola vaccine V920
NewLink Genetics (NASDAQ:NLNK) reported today that Merck has begun the submission of a rolling Biologics License Application (BLA) to the U.S. Food and... October 22, 2018
DBV Technologies Announces Submission of Biologics License Application for Viaskin Peanut to the U.S. Food and Drug Administration
DBV Technologies (Euronext: DB – ISIN: FR0010417345;Nasdaq:DBVT) today announced the submission of a Biologics License Application (BLA) to the U.S.... August 29, 2018
Evolus Receives Acceptance of FDA BLA Resubmission for DWP-450
Evolus (NASDAQ:EOLS), a company dedicated to aesthetic medicine, today announced the acceptance of its resubmission of its Biologics License Application... April 30, 2018
Sanofi: FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
The U.S. Food and Drug Administration (FDA) has accepted priority review the Biologics License Application (BLA) for cemiplimab for the...
April 6, 2018