FDA’s July calendar features at least 10 decision dates

FDA enters July with at least 10 scheduled drug and biologics decisions, including several resubmissions and a cell therapy whose action date was pushed back from April.

Orca Therapeutics B.V. appears to be anticipating good news about Orca-T, an allogenic cell therapy to treat hematological malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndromes (MDS). Last week the company announced that it had expanded manufacturing capacity ahead of a potential launch. The PDUFA delay to July 7 followed submission of CMC data. ...