5 updates on FDA’s expedited drug review activity
The FDA has fast-tracked six therapies since December 2025 through its priority review and National Priority Voucher programs, including the first approval issued under the agency’s new pilot pathway. 1. First voucher approval issued. On Dec. 9, the FDA approved Augmentin XR, an oral antibacterial for community-acquired pneumonia and acute bacterial sinusitis. The decision marked […]
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