In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

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 ...

In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor 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 ...

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

NRX-100 (preservative-free ketamine) has been granted Fast Track Designation by FDA for treatment of suicidal ideation in ...

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.