The days may be getting shorter, but the US FDA shows no signs of slowing down, handing out three new product approvals and one complete response letter on Nov. 2.
Keeping Track: FDA Starts November With A Bang
The latest drug development news and highlights from our FDA Performance Tracker.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.