For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for...
For Immediate Release: December 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced recommended changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder. The recommended changes intend to encourage the submission of...
What Did the Research Discover? Gastric and gastroesophageal junction (G/GEJ) cancers are among the deadliest cancers, and while immunotherapy has become a standard treatment for advanced cases, its role in earlier-stage disease is not well understood. The PANDA trial investigated whether neoadjuvant (before surgery) immunotherapy combined with chemotherapy could...
What Did the Research Discover? Primary biliary cholangitis (PBC) is a rare liver disease that gradually damages the bile ducts, leading to liver scarring. If left untreated, it can progress to cirrhosis and severe liver disease. The current first-line treatment, ursodeoxycholic acid (UDCA), does not work for up to 40% of patients, and the second-line option,...
What Did the Research Discover? Post-inflammatory hyperpigmentation (PIH) is a condition where dark spots appear on the skin after an injury, inflammation, or irritation. It is especially challenging to treat in people with darker skin tones (Fitzpatrick skin types IV-VI) because their skin naturally has more melanin, which can make treatments more difficult and...
What did the research discover? This study found that nearly one-third (32%) of patients with acute low back pain (LBP) transitioned to chronic LBP within six months. The risk of developing chronic pain was significantly associated with: Higher scores on the Subgroups for Targeted Treatment Back Tool (SBT), which predicts persistent functional limitations. Exposure...