Browsing Tag
Biologics License Application
4 posts
FDA nod sends Organogenesis shares higher as ReNu eyes BLA filing for knee osteoarthritis pain
Find out how Organogenesis’ FDA alignment clears the path for a ReNu BLA filing in knee osteoarthritis pain and why investors are paying attention now.
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)…
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.…
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…