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- Celcuity waits on FDA review of second plant as cancer drug rollout lags expectationsCelcuity has announced that it is awaiting the U.S. Food and Drug Administration’s review of a second manufacturing facility needed for its newly approved cancer therapy. The company explained tha…
- 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…