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- FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in ChinaThe U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
- European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversightA trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…