With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
Guidance for diabetes drug Mounjaro is $3.5 billion, while weight loss drug Zepbound is expected to bring in $1.9 billion for the quarter. In the latest weekly prescription tracking from JPMorgan ...
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
Key guidance to industry on enhancing diversity in clinical trials of cancer drugs disappeared from the Food and Drug Administration website. The page for Project Equity, a 2021 initiative ...
The Food and Drug Administration has removed webpages about diversity and inclusion in clinical trials for cancer drugs. The page for Project Equity, a 2021 initiative launched by the FDA's ...
An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of ...