BIMZELX(R) (bimekizumab-bkzx) Three-Year Rheumatology Data at ACR 2025 Demonstrated Sustained Inflammation Control in Psoriatic Arthritis and Axial Spondyloarthritis

UCB, a global biopharmaceutical company, today announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX (R) (bimekizumab-bkzx) in adults with active ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Monthly Prescribing Reference

FDA: Administration Mix-Ups Prompt Tranexamic Acid Injection Label Changes

A Boxed Warning explaining the risk of medication errors involving inadvertent neuraxial administration will be added to the labeling. The Food and Drug Administration (FDA) has issued an updated ...
Hosted on MSN

FDA asked to update label on acetaminophen

A petition asks the FDA to change the label to better reflect research about a possible connection between acetaminophen use during pregnancy and autism. Trump administration looking to sell nearly ...
Yahoo Finance

Roche's Gazyva Secures FDA Nod for Label Expansion in Lupus Nephritis

Roche RHHBY announced that the FDA has approved a regulatory filing seeking the label expansion of Gazyva/Gazyvaro (obinutuzumab) to treat adult patients with active lupus nephritis (LN) who are ...
KY3

Maker of Tylenol pushing back on FDA proposal to add label suggesting link to autism

(CNN) - The maker of Tylenol is pushing back on a proposed change to the product’s safety label. Kenvue said the U.S. Food and Drug Administration should not change Tylenol’s label to reflect possible ...
Straight Arrow News on MSN

FDA issues drug recall for cancer-causing impurity in blood pressure pill

The Food and Drug Administration is recalling a popular blood pressure drug after tests found a potential cancer-causing chemical.