The US FDA approved six novel agents over the first three weeks of May, representing the work of six different review different divisions. The new approvals account for a little more than a quarter of the 23 novel agents that the FDA has approved in all of 2023, and address a gamut of diseases in markets as large as dry eye disease, menopause and respiratory syncytial virus (RSV) and as orphan as dystrophic epidermolysis bullosa (DEB) and Fabry disease.
Keeping Track: Genmab/AbbVie Epkinly, Krystal’s Vyjuvek Join US FDA’s 2023 Novel Approvals List
Oncology's surprisingly low numbers this year are among the latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.