September 25, 2026

FDA monthly preview: Key October decisions to watch

Several FDA decisions across multiple specialties are expected this month.

MDSpire News

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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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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September 08, 2026

FDA approves serial liquid biopsy testing

In SERENA-6, patients who changed treatment following detection of an ESR1 mutation had a 56% lower risk of disease progression or death.

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September 01, 2026

FDA expands essential thrombocythemia care

Phase 3 SURPASS ET data showed higher durable response rates with ropeginterferon alfa-2b-njft than with anagrelide.

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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.

MDSpire News