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.

MDSpire News

October 28, 2026

NUT carcinoma may defy typical staining patterns

Two pulmonary cases highlight how limited squamous differentiation and variable keratin expression may complicate pathological diagnosis.

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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 26, 2026

Cryptococcal cellulitis may lead to amputation

A splinter injury progressed to finger necrosis in a patient with MDS, despite antibacterial treatment and no clinically apparent systemic dissemination.

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October 26, 2026

Vampire bats may link Chagas cycles

Molecular screening detected Trypanosoma cruzi in 42% of sampled bats in northern Belize, raising questions about their role in parasite transmission.

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October 23, 2026

FDA raises TMB threshold for pembrolizumab

Traditional approval narrows eligibility for previously treated solid tumors after efficacy was not confirmed at lower biomarker levels.

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October 19, 2026

FDA approves dostarlimab for advanced rectal cancer

The accelerated approval adds an immunotherapy option for patients with MSI-H/dMMR stage II/III disease.

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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 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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