Good Clinical Practice (GCP), the bedrock of ethical and high-quality clinical research, guides operations among sponsor companies, contract research organisations (CROs), investigator sites, and ...
We knew it was coming, and now it’s close. By the end of 2024, the US Food and Drug Administration (FDA) is expected to formally make reviews by a single institutional review board (sIRB) the standard ...
The FDA has approved inebilizumab-cdon (Uplizna, Amgen) for adults with anti-acetylcholine receptor and anti-muscle specific tyrosine kinase antibody positive generalized myasthenia gravis, according ...
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