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- FDA finalizes guidance on prescription drug appsThe US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and label software applications (apps) used alongside prescription medicines…raps · 23h ago↗ source
- FDA, MHRA officials eye streamlined frameworks for regulating genAIBoston – Regulators from the US and UK discussed ongoing efforts to develop regulatory frameworks that are better suited to generative artificial intelligence (genAI) products at The MedTech Confer…raps · 23h ago↗ source
- Roche signs $15 billion ADC partnership with China's Hansoh, offering $400 million upfrontRoche announced a licensing agreement with Hansoh Pharmaceutical to develop a broad portfolio of antibody-drug conjugates (ADCs).\n\nThe deal includes an upfront cash payment of $400 million and a…