Articles related to REGULATORY AFFAIRS

The Aptima HPV assay uses messenger RNA detection to identify infections most likely to lead to cervical cancer.

Twelve months after transplantation with the lower dose, mean scores decreased by 30.6 points during off time (a 52.82% improvement from baseline) and by 12.9 points during on time (a 54.67% improvement).

“We are surprised and disappointed by this FDA decision for EBV+ PTLD patients who have a significant unmet need, highlighted by tabelecleucel’s orphan drug designation and by the granting of breakthrough status.” — Dr. Cokey Nguyen, Atara CEO

“The FDA is failing women by denying access to a hormone their bodies naturally produce.” — Kelly Casperson, MD

A device that restricts blood flow and is worn around the neck, that has not been shown to provide any clinical benefit, is being sold to vulnerable populations—including children as young as 13.

“There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome. The microbiome is increasingly recognized to be central to a child’s health and development.”