Setback for diabetes innovation: FDA puts brakes on Novo Nordisk’s once-weekly insulin icodec
Novo Nordisk announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application for its ... Read More
Eisai initiates rolling submission for Leqembi autoinjector BLA to FDA
BioArctic AB's partner Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb ... Read More
Biocon Biologics secures license agreement for biosimilar launch in US
In a landmark announcement, Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, revealed its settlement and license ... Read More