The FDA has approved the first generic versions of Johnson & Johnson's big-selling anticoagulant Xarelto, which brought in nearly $2.4 billion in US sales last year. The US regulator has cleared 2.5mg ...

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In another move designed to reduce the US' reliance on imported medicines, the FDA has launched a pilot of fast-track reviews for generics tested and made in domestic facilities. According to the ...

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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, ...