FDA Activity Round Up – July 2026
• The FDA has proposed a new hub-and-spoke manufacturing registration rule and approved three new drugs targeting bladder cancer, IgA nephropathy, and multiple myeloma. • A key industry trend highlighted is the shift from intravenous biologics to subcutaneous injectables to reduce patient infusion times and increase clinic capacity. • This transition requires manufacturers to implement complex new fill-finish processes, device-drug combination quality systems, and rigorous safety testing for end-users.
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