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 ...

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 ...

Sevabertinib received FDA accelerated approval for nonsquamous NSCLC with HER2 TKD mutations, based on the SOHO-01 trial results. Patients naïve to HER2-targeted therapies showed a 71% ORR and a ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

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

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...