Bristol-Myers Squibb's Pravachol (pravastatin) 10 mg is an attractive candidate for OTC status, but the company should first conduct additional label comprehension studies and better define the target population for the cholesterol agent, FDA advisory committee members suggested July 14.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
