Top-line results from Phase III bone metastasis prevention trial lift stock price and inspire bullish headlines for Amgen. But vital figures and proof of clinical benefit are missing, making study tougher to interpret.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.
The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
