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

Is this the Next Botox? Evolus’s Phase 3 Study Met Primary Endpoints

Botox has long been one the best solutions for smoothing wrinkle lines, managing skin breakouts, lifting lips and more, but...