Regulatory Updates

The Alzheimer's Association praises the approval but not the price tag. A Harvard Medical School professor who resigned from an FDA advisory committee says the OK "was probably the worst approval decision in recent U.S. history" in his resignation letter.

Today's approval goes against the advice of an outside advisory committee.

Semaglutide injection is a weekly injection for chronic weight management in adults.

About 2% to 3% of patients with nonsmall cell lung cancer have EGFR exon 20 insertion mutations targeted by newly approved Rybrevant.

OptumRx had identified pegcetacoplan as one of the top 5 drugs in the pipeline this year.

The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.