October 29, 2026

FDA, CMS target gene therapy barriers

FDA and CMS initiatives aim to simplify gene therapy approvals and expand access to treatments for rare diseases.

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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 15, 2026

Anticoagulant recalled over life-threatening risk

Contamination in 22 lots of the injection may cause pulmonary embolism or vascular occlusion; no related adverse events reported.

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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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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 21, 2026

FDA approves combo for ESR1-mutated breast cancer

In an exploratory subgroup analysis of patients with ESR1-mutated tumors, median progression-free survival was 11.1 months with the combination and 5.5 months with imlunestrant alone.

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September 15, 2026

Photodynamic therapy gains FDA approval for superficial BCC

Phase 3 trial data showed greater clinical and histological clearance than with placebo photodynamic therapy.

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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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