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- How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and MedicineAs AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
- FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst salesThe FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…