FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.
A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and federal reimbursement policies that it says are threatening the long-term sustainability of the generic and biosimilar markets.
FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.
A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and federal reimbursement policies that it says are threatening the long-term sustainability of the generic and biosimilar markets.
FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome in children 4-11 years old.
FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with atezolizumab, for treating patients with metastatic colorectal cancer.
