Articles related to FDA

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.

Sanbexin’s sublingual formulation offers a potential paradigm shift in acute ischemic stroke treatment, enabling flexible administration outside traditional hospital settings.

The FDA’s new mandate requires all mammography facilities to inform women about their breast density, recognizing its significance in cancer risk and detection challenges.