Keeping Track: US FDA Novel Approvals Return With Xenpozyme, Spevigo Nods; Stimufend Survives COVID-19 Delays
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
The German firm’s monoclonal antibody has received a US thumbs-up for a severe skin disease with high unmet need but it must address diagnostic and educational hurdles.