Forbes

New Pancreatic Cancer Drug Nearly Doubles Survival. Here’s What Patients Should Know

This voice experience is generated by AI. Learn more. This voice experience is generated by AI. Learn more. Former Senator Ben Sasse has become an unlikely public face of a drug that researchers are ...
RAPS

FDA issues draft guidance clarifying differences between ANDAs and 505(b)(2) applications

The US Food and Drug Administration (FDA) has updated its seven-year-old guidance to clarify the differences among abbreviated approval pathways and the data it will accept for these applications.
RAPS

FDA finalizes guidance on formal meetings with drug and biologics sponsors

The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and ...