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- FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standardsThe U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
- Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potentialMerck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…