July 30, 2026

FDA Monthly Preview: Key August Decisions to Watch

Several FDA decisions across multiple specialties are expected this month.

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July 27, 2026

FDA Approves Centanafadine for ADHD

The first approved norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD demonstrated symptom improvements as early as week 1 in phase 3 trials.

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July 24, 2026

FDA Approves Acetaminophen/Naproxen Sodium

The fixed-dose combination product combines acetaminophen with naproxen sodium and is labeled to provide up to 12 hours of temporary pain relief.

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July 22, 2026

FDA Expands Pediatric Allergy Nasal Spray Use

A phase 3 randomized, double-blind, placebo-controlled trial in pediatric patients demonstrated improved nasal symptoms compared with placebo.

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July 17, 2026

FDA Grants Traditional Approval to Iptacopan in Primary IgAN

Novartis reported less annual eGFR decline with iptacopan than placebo over 2 years in the phase 3 APPLAUSE-IgAN trial.

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July 17, 2026

FDA Approves New Iohexol Vials

The approval includes additional 300 mg iodine/mL and 350 mg iodine/mL vial presentations.

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July 17, 2026

FDA Probes Taco Bell Cyclospora Outbreak

FDA's traceback investigation identified a single supplier of iceberg lettuce from Mexico. The agency has initiated product sampling, increased border screening, and said Taco Bell plans to stop using lettuce from the identified supplier.

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July 17, 2026

ADHD Stimulant Misuse Under Review

High-frequency misuse remains associated with polysubstance use, while no studies evaluated long-term physical health outcomes.

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July 15, 2026

CDC Updates Cyclosporiasis Surveillance

More than 5,100 additional reports require further analysis as federal and state partners investigate several outbreaks and work to identify their sources.

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July 15, 2026

FDA Classifies Medtronic Harmony Recall as Class I

Distal tip detachment during implantation may necessitate retrieval of the detached tip through an endovascular or surgical procedure.

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