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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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.
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.