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 the first approval under the Commissioner’s National Priority Voucher pilot program.
2. J&J multiple myeloma therapy accepted.
On Dec. 15, the FDA accepted a supplemental application for teclistamab (Tecvayli) in combination with Darzalex Faspro. The therapy received both a breakthrough designation and a voucher for expedited review.
3. Two more vouchers granted.
On Dec. 19, the agency awarded vouchers to enlicitide decanoate, an oral PCSK9 inhibitor for lowering LDL cholesterol, and sacituzumab tirumotecan, an antibody-drug conjugate targeting trophoblast cell-surface antigen 2.
4. Alzheimer’s agitation drug accepted.
On Dec. 31, the FDA granted priority review to AXS-05, a therapy for agitation associated with Alzheimer’s disease. A target action date was set for April 30.
5. 1st therapy to delay Type 1 diabetes in children under 8 accepted. The FDA has accepted a supplemental application for Sanofi’s Tzield to expand its approved use to children as young as 1 year old with stage 2 Type 1 diabetes, according to a Jan. 5 company news release from the drugmaker. If approved, it would become the first disease-modifying therapy to delay the onset of stage 3 in this age group. The agency set an action date of April 29.
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