All articles by Milena Izmirlieva

FDA shows unease about marketing approval applications based on single-country trials

Several reasons specified in the ODAC rejection are specific to the sintilimab BLA.

Is price control by stealth the future for the United States?

There may be ways to introduce price control under federal drug programmes by stealth in the absence of state price negotiations.

Seven years on ICER’s review process remains unpredictable