Move follows actions "inconsistent with proper research conduct," journal says ...
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 ...
Adults with mantle cell lymphoma who have already failed two or more treatments, including a BTK inhibitor, now have a new targeted option. The FDA granted accelerated approval to sonrotoclax, sold ...
How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025? While it would be presumptuous to base conclusions solely ...
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...
Until recently, the transaction landscape for psychedelic treatment centers in the United States has been defined almost ...
In oncology, the introduction of novel therapies has progressed, leading to an improvement in the survival rates of patients with cancer compared with those in the early 2000s 1. However, there are ...
– First and only hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language – Next-generation, MRI-compatible device expected ...