October 27, 2026

FDA expands talazoparib use in prostate cancer

The combination with enzalutamide reduced the risk of radiographic progression or death by 52% .

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October 14, 2026

FDA expands bladder cancer therapy approval

The expansion offers another treatment option for patients with high-grade tumors following BCG failure.

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October 09, 2026

FDA approves atezolizumab for dMMR colon cancer

In the phase 3 ATOMIC trial, adjuvant atezolizumab plus chemotherapy halved the risk of recurrence or death in stage 3 patients.

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September 28, 2026

FDA approves new treatment for FOP

Total new heterotopic ossification volume decreased with treatment and increased with placebo at week 24.

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September 25, 2026

FDA monthly preview: Key October decisions to watch

Several FDA decisions across multiple specialties are expected this month.

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September 24, 2026

FDA approves combo for advanced renal cell carcinoma

Median progression-free survival was 15 months with the combination vs. 11 months with cabozantinib in the LITESPARK-011 trial.

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September 24, 2026

FDA clears targeted cholangiocarcinoma therapy

In the single-arm REFOCUS trial, 46% of patients responded to treatment, with a median response duration of 11.8 months.

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September 14, 2026

FDA approves FET-PET agent for glioma

The radioactive diagnostic drug is indicated in patients aged 1 month or older and is used in conjunction with other diagnostic evaluations.

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September 09, 2026

FDA expands sevabertinib approval in NSCLC

SOHO-01 data showed a 75% confirmed objective response rate among 69 patients without previous systemic therapy.

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August 28, 2026

FDA monthly preview: Key September decisions to watch

Several FDA decisions across multiple specialties are expected this month.

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