Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.
A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.
Sanofi’s $1.9bn cash purchase of Kadmon surprised many analysts, coming as a bolt-on for the French pharma’s general medicines transplant portfolio rather than its specialty care pipeline, but the overall view was that it made sense.