FDA approves StemCyte’s cord blood stem cell therapy BLA
The US Food and Drug Administration (FDA) has granted approval for StemCyte's biologics license application (BLA) for REGENECYTE, a hematopoietic progenitor cell (HPC), Cord Blood product.
The US Food and Drug Administration (FDA) has granted approval for StemCyte's biologics license application (BLA) for REGENECYTE, a hematopoietic progenitor cell (HPC), Cord Blood product.
Dyadic International has received a $3m grant from the Bill & Melinda Gates Foundation to develop monoclonal antibodies (mAbs) for the treatment of respiratory syncytial virus (RSV) and malaria.
Laekna has entered into a clinical partnership with Eli Lilly to advance the development of LAE102, a new ActRIIA monoclonal antibody for treating obesity.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Ractigen Therapeutics' new therapy, RAG-21, targeting the fused in sarcoma (FUS) gene, for amyotrophic lateral sclerosis (ALS) treatment.
Arrowhead Pharmaceuticals has submitted a new drug application (NDA) for plozasiran to the US Food and Drug Administration (FDA) to treat familial chylomicronemia syndrome (FCS).
The US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in adults and children aged 12 and above, particularly for those whose condition persists despite H1 antihistamine treatment.
Asha Therapeutics has received a grant from the ALS Association through its Lawrence and Isabel Barnett Drug Development Program for advancing ASHA-624 to treat amyotrophic lateral sclerosis (ALS).
AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat non-small cell lung cancer (NSCLC).
Alteogen has entered into an exclusive license agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous version of ENHERTU (fam-trastuzumab deruxtecan-nxki), an antibody drug conjugate (ADC).
New England Biolabs (NEB) has expanded its global footprint with the opening of NEB Lyophilization Sciences (NEB Lyo Sciences), a manufacturing facility in the UK.