Drug Manufacturing

Valneva submits application seeking FDA approval for IXCHIQ for adolescent use

Valneva has submitted an application to the US Food and Drug Administration (FDA) seeking approval for a label extension of its chikungunya vaccine, IXCHIQ.

FDA accepts Alnylam’s vutrisiran sNDA to treat ATTR-CM

The US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) of Alnylam Pharmaceuticals’ vutrisiran for review.

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.

Dyadic receives grant from Gates Foundation for RSV antibody development

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 partners with Lilly to develop obesity therapy

Laekna has entered into a clinical partnership with Eli Lilly to advance the development of LAE102, a new ActRIIA monoclonal antibody for treating obesity.

FDA grants ODD to Ractigen Therapeutics’ RAG-21 for ALS treatment

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 submits plozasiran NDA to treat FCS

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).

FDA to review Sanofi, Regeneron’s Dupixent sBLA for CSU

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 secures grant for ALS therapeutic development

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).