46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

In this part 3 of our three-part interview, Stenberg explores the evolving manufacturing paradigm in the pharmaceutical ...

The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

The Eisai- and Biogen-partnered Alzheimer’s disease drug Leqembi has been available to date as an intravenous infusion that takes about an hour. Patients will soon have the option to choose an ...