When the US Food & Drug Administration approved MacroGenics, Inc.’s metastatic breast cancer treatment Margenza (margetuximab-cmkb) on December 16, it didn’t get a whole lot of attention.
The US FDA’s Nifty Fifty
FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
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Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
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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.
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The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.