December 19, 2024

FDA Redefines 'Healthy' Food Claims

The regulation requires qualifying foods to contain amounts from at least one food group or subgroup referenced in the Dietary Guidelines for Americans.

Conexiant

December 19, 2024

FDA Rejects New Bowel Disease Drug

The FDA declined to approve Zealand Pharma's bowel disease drug and sought an additional trial to confirm the drug's safety and efficacy, impacting thousands of adult patients in the United States.

Reuters

December 18, 2024

FDA Flags Serious Risk in Catheter Recall

The FDA has issued a 'most serious' classification for the recall of Boston Scientific's catheters used in minimally invasive surgery, linked to reports of esophageal injury and fatalities.

Reuters

December 18, 2024

USPSTF Challenges Common Supplement Use

"Unfortunately, when we reviewed the latest evidence, we found that taking vitamin D with or without calcium does not prevent falls or fractures in older adults."

Conexiant

December 18, 2024

First Severe U.S. Bird Flu Case Confirmed

The U.S. reports its first severe human case of bird flu, impacting dairy herds and farm workers. California declares an emergency over the H5N1 virus as it spreads more widely and infects dozens of workers.

Reuters

December 18, 2024

FDA Approves Mesoblast's Therapy for GVHD

FDA approves Mesoblast's cell therapy for treating graft-versus-host disease after stem cell or bone marrow transplants.

Reuters

December 17, 2024

Trump's Health Picks Clash on Vaccines, Policy

The selection of individuals for federal health agencies under President-elect Donald Trump presents conflicting views on matters such as abortion limits, vaccine safety, covid-19 responses, and the use of weight-loss medications.

KFF Health News

December 17, 2024

FDA Rejects J&J’s Injectable Lung Cancer Drug

FDA declines to approve Johnson & Johnson's Rybrevant injectable for non-small cell lung cancer due to observations during pre-approval inspection unrelated to drug formulation, efficacy, or safety. J&J is working to resolve the issues.

Reuters

December 17, 2024

FDA Targets Unapproved GLP-1 Drug Sellers

The FDA has issued warning letters to companies for selling unapproved versions of popular diabetes and weight-loss drugs. The companies falsely labeled products for 'research use only' despite evidence showing they are intended for human use.

Reuters