FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

FDA Grants Priority Review to Sibeprenlimab for the Kidney Disease IgAN

Sibeprenlimab would be offered in a prefilled syringe for subcutaneous injection. The PDUFA target action date is Nov. 28, 2025.

FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

With the priority review acceptance of the Biologics License Application, the FDA has assigned a PDUFA target action date of November 28, 2025.

FDA committee votes in favor of Darzalex Faspro for HR-SMM

A U.S. Food and Drug Administration (FDA) committee has voted in favor of Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat high-risk smoldering multiple myeloma (HR-SMM). The FDA’s Oncologic Drugs Advisory Committee voted 6 to 2 in favor of the benefit-risk profile of Darzalex Faspro in HR-SMM, which refers to early signs of inactive myeloma that is not yet causing any overt symptoms but where there is a high likelihood of progressi…

FDA to review Otsuka's application for IgAN treatment

The US FDA has accepted for review Otsuka Pharmaceutical’s biologics licence application (BLA) for the monoclonal antibody, sibeprenlimab.