FDA actions, week of October 26, 2026: 1 approval, 1 notice
The FDA published 2 actions so far in the week of October 26 to November 1, 2026: 1 approval announcement and 1 notice in the Federal Register.
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This page updates as the week's records arrive. The week ends on Sunday, November 1, 2026.
Approvals
- FDA approves talazoparib with enzalutamide for metastatic prostate cancer. On October 26, 2026, the FDA approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, as detected by an FDA-authorized test. The TALAPRO-3 trial showed median radiographic progression-free survival not reached (95% CI: NR, NR) versus 45.8 months (95% CI: 37.7, NR) with a hazard ratio of 0.48 [95% CI: 0.36, 0.65]; p<0.0001. Source: FDA approval page, October 26, 2026.
Notices
- FDA issues priority review voucher for ISEMBYLD (apitegromab-mstn). The FDA announced the issuance of a priority review voucher to the sponsor of ISEMBYLD (apitegromab-mstn), approved September 11, 2026. The voucher is awarded because the product meets the criteria for rare pediatric disease applications under the FD&C Act. Source: Federal Register notice, October 26, 2026.
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