The FDA approved the addition of Guillain-Barré syndrome warnings for Abrysvo and Arexvy, citing postmarketing data suggesting an increased risk.

In an unusual step, the agency's draft guidance recommends the efficacy benchmark for drug approval while emphasizing clinical trial structure and cohort development.

Johnson & Johnson's posdinemab aims to slow tau pathology in early and preclinical Alzheimer’s disease populations.

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Significant strides were made in 2024 in evaluating a wide range of treatments for migraine, including phase 2 findings with PACAP inhibition, PI McAllister said.

The first study to quantify lecanemab-captured Aβ-PF species in human CSF shows a strong correlation with neurodegeneration and may help explain the drug's MOA.

The updated guidelines include 19 recommendations related to the diagnosis and management of eosinophilic esophagitis.

The bird flu threat remains low, according to public health authorities, but awareness and vigilance will help keep it that way. Here are 9 things you need to know.

The first death of an American from the H5N1 virus was reported in Louisiana on Monday, though authorities maintain the risk of widespread infection remains low.

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The onset of migraine with its wide range of symptoms may be telegraphed as early as 2 days before by the frequency of neuronal oscillation deep in the brain.

Sanofi and SK bioscience expand collaboration on pneumococcal conjugate vaccines, including a 21-valent candidate for pediatric populations.

The 2025 rankings released by U.S. News & World Report featured 13 new diets and 12 new categories.

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Murthy's advisory outlines evidence for the cancer-alcohol relationship and calls for greater efforts to increase public awareness of the risks from beer, wine, and spirits.

The USPSTF's revised CRC screening guidelines to include adults aged 45-49 years increased screening needs by about 23% without additional funding or resources for CHCs.

The failure of the novel kappa opioid receptor antagonist to best placebo in the first of triplicate phase 3 studies has Neumora concerned but not deterred.

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In November 2024, an FDA advisory committee said the benefits of sotagliflozin do not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.

Daily step counts of 5000 or more corresponded with fewer depressive symptoms, according to a recent systematic review and meta-analysis.

Panelists discuss how untreated obstructive sleep apnea (OSA) significantly increases patients’ risk of serious health complications, including cardiovascular disease, type 2 diabetes, depression, and cognitive impairment while exacerbating existing comorbidities.

The new chemical entity from Xgene Pharmaceuticals, XG005, targets both anti-nociceptive and anti-neuropathic pain pathways.

NX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA.

Geriatric psychiatrist and neurocognitive researcher George Grossberg, MD, highlights the mechanism of action for the new dextromethorphan/bupropion combination.

Axsome plans to submit a New Drug Application to the FDA in the second half of 2025 that is based on positive results from 4 pivotal phase 3 clinical trails and long-term data.