Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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The European Medicines Agency has OKd two new H5N1 jabs, including a pandemic preparedness vaccine intended for use only if a flu pandemic is declared. Eight other products are also heading for EU-wide approval.
Developers of three new drugs, including two orphan medicines, that are nearing the final stages of their EU regulatory review cycle could be asked to explain why the European Medicines Agency should recommend approval of their products.
The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing authorization for a number of new products.