Latest From Sue Sutter
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.
Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen’s ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance.
Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssen’s Stelara.
FDA Cancer Center’s New ‘Projects’ Focus On Early Endpoints; Asian American, Native Hawaiian Populations
Launched in 2023, Project Endpoint focuses on advancing understanding of early, novel endpoints, while Project ASIATICA aims to bring greater awareness of challenges and health disparities faced by Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer.