The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...

Dr Marks formally resigned from his post on 28th March and is due to step down on 5th April, and his resignation letter ...

Cabozantinib, an oral tyrosine kinase inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated advanced neuroendocrine ...

Global harmonization of CGT regulations could expedite access to innovative therapies by standardizing evaluation and regulatory processes. Only 20% of trials submitted to both the FDA and EMA had ...

Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory ...

varying regulatory requirements across different regions are hindering cell and gene therapy (CGT) adoption. The US Food and Drug Administration (FDA)’s donor eligibility guidelines from 2007 ...