GlobalData on MSN
FDA prevails over EMA in 2025 novel drug approvals
This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
2don MSN
Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
6 min read | UniQure secured a Type A FDA meeting, a high-priority discussion for urgent issues. Within 30 days, both sides will discuss what kind of data package might support the advancement of ...
Please provide your email address to receive an email when new articles are posted on . The FDA based nerandomilast’s approval on results from two trials, one of which was the FIBRONEER-IPF trial.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback