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.
Fresenius Kabi’s Q1 call spanned its recent launch of a generic version of Takeda’s Velcade subcutaneous injectable to the company’s continued ambitions in biosimilars, with the German firm’s acquisition of a controlling stake in mAbxience scheduled to close by the middle of the year.