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.

Inluriyo, an oral estrogen receptor antagonist, significantly reduced disease progression risk in ESR1-mutated metastatic breast cancer, as shown in the EMBER-3 trial. Keytruda Qlex, a subcutaneous ...

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 ...

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 ...

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 ...