Keeping Track: Myovant, Almirall, MacroGenics Nab Novel Approvals; Novartis’ Inclisiran Delayed
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.
FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.
Myovant's Orgovyx was just approved by the US FDA for prostate cancer and could be approved soon for two women's health indications.