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The FDA set the Prescription Drug User Fee Act (PDUFA) date for December 16, 2025.

Investigators concluded that dupilumab reduced exacerbation rates, improved lung function, and decreased systemic corticosteroid use in patients with COPD driven by type 2 inflammation.

The FDA approval of neffy 1 mg follows the earlier approval of the 5 mg version in August 2024.

AAAAI 2025: Data from the ANCHOR-1 and ANCHOR-2 phase 3 trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing vs placebo.

The first low-dose rivaroxaban generic tablets to be FDA approved lead a field crowded with applications for formulations of all the higher doses.

New evidence-based guidance for bowel prep considers patient preference and history and updates timing of prep regimen, dietary restrictions, and follow-up recommendations.

Overweight individuals in the highest dose group with weight loss at day 28 continued to lose weight at the 2-week follow-up, with metabolic changes mimicking ketogenic effects.

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Posing an unparalleled threat of premature disease and death globally, the unchecked rise in overweight and obesity requires an urgent 5-year action plan, experts say.

Axsome Therapeutics reported that the FDA feedback supports the company's regulatory package for a sNDA for the dextromethorphan/bupropion combination.

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They are a Janus kinase (JAK)1/JAK2 inhibitor, a phosphodiesterase-4 inhibitor, and an investigational aryl hydrocarbon receptor agonist. Learn more about each.

Two official US vaccine planning meetings cancelled in February is an "unprecedented situation," said NFID medical director Robert Hopkins, Jr, MD.

Safety findings from the phase 3 OUtMATCH trial were notable, including no adverse events for omlizumab vs 30.5% for OIT and epinephrine use for 0% vs 37.3%, respectively.

The investigational once-daily oral analgesic, a potent inhibitor of a novel target for neuropathic pain, achieved meaningful pain reduction vs placebo.

Your daily dose of the clinical news you may have missed.

Participants (aged 6 to 17 years) receiving neffy vs standard treatments had fewer skin, gastrointestinal, and respiratory symptoms at 15, 5, and 5 minutes, respectively.

Shahriari, assistant clinical professor of dermatology at Yale University School of Medicine, says greater understanding of the condition has expanded the population for the diagnosis.