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FDA accepts pSivida's marketing application for Durasert for PSU, action date November 5; shares ahead 5%

Published 03/19/2018, 12:45 PM
© Reuters.  FDA accepts pSivida's marketing application for Durasert for PSU, action date November 5; shares ahead 5%
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  • The FDA accepts for review pSivida's (PSDV +4.9%) marketing application seeking approval for Durasert for the three-year treatment of posterior segment uveitis (PSA). The agency's action date is November 5.
  • Durasert is a miniaturized injectable sustained-release drug delivery system for small molecules (up to three years). The implant can be administered in an office setting via a needle as small as 25-gauge.
  • Previously: pSivida's Durasert shows treatment benefit at month 12 in second late-stage PSU study, U.S. marketing application submitted (Feb. 8)
  • Now read: Your Daily Pharma Scoop: Adamas' Gocovri Key Value Driver, BioMarin Data, Regeneron Q4 Results


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