The CDC recommends a single dose of any FDA-approved RSV vaccine for all adults ages 75 years and older, as well as for 60- ...

FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk.

A recall notice shared to the U.S. Food and Drug Administration website on Tuesday warned customers of St. Louis-based ...

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.

GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing ...

The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this ...

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

The FDA is alerting healthcare providers about a potential high-risk issue with certain Baxter Healthcare Solution Sets with Duo-Vent Spikes. Baxter has issued a recall for several lots of these ...

The FDA granted priority review to sunvozertinib for the treatment of advanced NSCLC with EGFR exon 20 mutations, based on ...

According to the FDA, 1 each of the unapproved products were sold on the firm’s websites, Amazon shops, and social media ...

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review ...