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Merck’s investigational hepatitis C grazoprevir/elbasvir combination pill has picked up two new breakthrough designations, just three months after the FDA threatened to rescind one it had already granted to the drugs. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Drugmakers can now make minor changes to drug safety assurance plans without waiting for FDA approval, reducing some of the burden of managing risk evaluation and mitigation strategies. Read More