Articles related to FDA

Manufacturing violations at an Indian facility have triggered a recall of 15 million OTC pain patches, raising concerns about product quality and patient safety across multiple widely-used brands.

Laboratory analysis reveals montelukast demonstrates “significant binding” to multiple brain receptors, suggesting more extensive neurological activity than previously understood.

The inavolisib-based regimen more than doubled progression-free survival in PIK3CA-mutated breast cancers, offering a new standard of care for this challenging patient population.

In the BLUE-C trial, Cologuard Plus demonstrated a 93.9% sensitivity for colorectal cancer detection, significantly outperforming the 67.3% sensitivity of FIT.

The CDC investigation revealed that the 65 people who contracted Salmonella from the outbreak ranged from 2 to 88 years old, highlighting the wide demographic susceptibility to foodborne illnesses.

The Epitomee capsule, a novel ingestible device for weight management, has shown promising results in clinical trials, with 55.5% of users losing at least 5% of their baseline body weight at 24 weeks.