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- Merck wins first approval of a PCSK9 cholesterol pillThe speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.BioPharma Dive · 14d ago↗ source
- Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drugWelcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.raps · 14d ago↗ source
- Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile productsThe European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.