Vanda urges FDA to drop proposal for extending drug review timelines; shares down
Shares of drugmaker Vanda Pharmaceuticals VNDA.O fall 1.4% to $7.19 in early trading
Co says it asked the FDA to withdraw a proposal that would lengthen reviews of new drug applications
Says the plan would scrap a law requiring drug reviews within 180 days and instead allow reviews to stretch 10–12 months
Adds the change could delay patient access to medicines and raise uncertainty for smaller drugmakers
The proposal would replace a formal appeal process for rejected drugs with a less rigorous internal review - VNDA
Including session's move, stock down ~19% YTD
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