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 ...
The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a ...
Gepotidacin, a new oral antibiotic class, was approved for uncomplicated UTIs, showing noninferiority to nitrofurantoin in phase 3 trials. Semaglutide's indications expanded to include cardiovascular ...
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 ...
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