US FDA Sends Amgen/UCB Evenity Back With BRIDGE Request
Executive Summary
The US FDA has surprised no-one with a Complete Response Letter for Amgen and UCB's novel osteoporosis treatment Evenity but, with luck, analysts say the product might still reach the market in 2018-19 and garner sales over £500m.
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Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear
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