Food and Drug Administration

Zimmer Biomet Receives FDA Clearance for Rosa Robotic-Assisted Total Shoulder Replacement System

Zimmer Biomet has received FDA 510(k) clearance for its Rosa robotic-assisted total shoulder replacement system, a significant advancement in orthopedic surgery. The system, designed for anatomic or reverse total shoulder replacement, is the latest addition to the company’s Rosa robotics portfolio. The Rosa shoulder system is set to be commercially available in the U.S. in the second half of 2024.

FDA Approves Omalizumab for Reduction of Allergic Reactions in Patients with Food Allergies

FDA approves omalizumab (Xolair; Novartis) as the first and only medicine to reduce allergic reactions in patients with food allergies. The drug is not for emergency treatment and patients should continue avoiding allergenic foods. Positive results from the phase 3 OUtMATCH study show potential for omalizumab to mitigate allergic reactions in patients with multiple food allergies.

FDA Concludes Investigation into Listeria Outbreak Linked to Recalled Fruit

The FDA has concluded its investigation into a Listeria outbreak linked to conventionally grown peaches, plums, and nectarines that were voluntarily recalled by HMC Farms. The outbreak resulted in 11 illnesses, 10 hospitalizations, and one fatality across seven states. The conclusion of the investigation provides important insights for food safety measures and regulations.

Montelukast (Singulair) Linked to Serious Mental Health Risks, Especially in Children

In a recent study, it has been discovered that the popular asthma and allergy drug montelukast, also known as Singulair, can potentially cause serious mental health risks, especially in children. Despite these alarming findings, the drug continues to be widely…

Florida Surgeon General Sparks Controversy with Call to Halt Covid Vaccines

Florida’s surgeon general, Dr. Joseph Ladapo, has sparked controversy by calling for a halt to the use of Covid vaccines, citing debunked concerns about contaminants in the vaccine permanently integrating into human DNA. In a statement released by the Florida…