Catalyst

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Brodalumab in Moderate-to-Severe Plaque Psoriasis PDUFA set for February 16 2017

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Additional Information

Additional Relevant Details FDA has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
http://ir.valeant.co...
Additional Relevant Details Update on 8 Nov 2016: PDUFA was originally set for November 16 2016, got delayed to February 16 2017
http://ir.valeant.co...
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Catalyst Date
Occurred on:
Feb 16, 2017
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Related Keywords Fda Acceptance, Bla Submission, Brodalumab, Plaque Psoriasis