Avidity Biosciences, based in San Diego, has aligned with the FDA regarding its product approval pathways. Mike Maclean serves as the company's CFO.
1 report, 1 independent
Updated Jul 28
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What happened
Avidity Biosciences, based in San Diego, has aligned with the FDA regarding its product approval pathways. Mike Maclean serves as the company's CFO.
Who's involved
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The entities involved
Related events
- FDA clearance enables market entry into the U.S. for an unnamed company, which is also navigating the long-term regulatory process in Japan.
- Avidity Biosciences, a San Diego-based company, announced a partnership with Eli Lilly and is also facing acquisition interest from Novartis.
- Bristol-Myers Squibb holds exclusive commercial rights in Japan after the FDA accepted Zenas's Biologics License Application.
Coverage
Newest first; wire copies grouped- PR NewswireAvidity Biosciences Announces Completion of Enrollment for HARBOR™, the First Global Phase 3 Trial of Delpacibart Etedesiran (del-desiran) for Treatment of DM1 and Provides Guidance on Regulatory Subm