Browsing Tag
Biologics License Application
7 posts
Could nomlabofusp become the rare disease catalyst that revalues Larimar?
Larimar’s rolling BLA and nomlabofusp data sharpen LRMR’s rare disease biotech story around Friedreich’s ataxia, frataxin and accelerated approval.
Could TSHA stock gain momentum as Taysha advances TSHA-102 toward a Rett syndrome BLA?
Find out how Taysha’s TSHA-102 Rett syndrome update could affect TSHA stock, BLA planning and rare disease gene therapy competition today!
uniQure surges 78% as FDA clears accelerated approval path for its Huntington’s disease gene therapy
uniQure (QURE) surges 78 percent as FDA clears accelerated approval path for AMT-130 in Huntington's disease, with BLA filing due Q3 2026. Full analysis.
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…