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 15, 2026

FDA revises monitoring for SCLC therapy

Initial monitoring decreases from 22 to 24 hours to 6 to 8 hours from the start of the first 2 infusions.

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September 14, 2026

FDA broadens APDS treatment options

An 8-patient study evaluated safety and pharmacokinetics in the younger pediatric population.

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September 14, 2026

FDA approves muscle-targeted SMA therapy

The therapy inhibits myostatin signaling and is used with survival motor neuron 2-targeted treatment.

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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 dual-energy AFib ablation catheter

The FDA based the authorization on results from Abbott’s FlexPulse study, which reported safety and effectiveness outcomes in paroxysmal atrial fibrillation.

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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 04, 2026

FDA approves first therapy for Alexander disease

The antisense oligonucleotide reduces production of the abnormal protein that accumulates in supportive cells in the brain.

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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 31, 2026

FDA approves hepcidin mimetic for PV

Phase 3 VERIFY results showed a 77% clinical response rate during weeks 20 to 32.

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