Valbenazine FDA Panel Cancellation Is A Good Sign, Neurocrine Says
US agency's decision not to hold a February advisory committee review of tardive dyskinesia treatment viewed positively by Neurocrine, which emphasized quality of its communications with the review division and the drug's breakthrough therapy status.
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Neurocrine's US Label For Ingrezza Should Provide Edge Over Teva's Austedo In TD
A summertime battle is expected between Neurocrine and Teva once both companies get their tardive dyskinesia drugs on the US market, but Neurocrine's April 11 approval for Ingrezza without an FDA warning label is already giving the biotech an edge.
Keeping Track: New Indication For Lucentis; New Lesinurad Application From Ironwood
The latest drug development news and highlights from our FDA Performance Tracker.
US FDA Has Slim Advisory Committee Schedule – A Sign Of Things Not To Come?
Agency has scheduled only two advisory committee meetings in 2017; does it indicate the agency plans to conduct fewer meetings going forward?