- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Alnylam Pharmaceuticals received regulatory approval for its lead drug in both the US and Europe.
2 reports, 1 independent
Updated Jul 2
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New informationRepeats or wire copies
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What happened
Alnylam Pharmaceuticals received regulatory approval for its lead drug in both the US and Europe.
Who's involved
What this event is mainly aboutKeep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
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Alnylam Pharmaceuticals
biopharmaceutical company
- AstraZeneca's trial failure has created a competitive advantage for Alnylam Pharmaceuticals, which is leveraging AI in its commercial execution.
- Alnylam Pharmaceuticals, SEC, Truist Financial, and Nasdaq were involved in insider trading disclosures, analyst ratings, and stock trading on June 6, 2026.
- FDA
Related events
- Both the FDA and the European Medicines Agency govern drug approval processes.
- The FDA and European Medicines Agency are harmonizing regulatory review of drug applications.
- A study author is based in Johns Hopkins School of Medicine, and the research is connected to Baltimore, now involving the FDA for drug approval.
- EMA validated marketing authorization and FDA accepted NDA for Pharvaris N.V.'s lead drug.
- FDA and Pfizer are seeking regulatory approval for their products.
Coverage
Newest first; wire copies grouped- BarchartProfits May Be Just Around the Corner for This Strong-Buy Pharma Stock Alnylam Pharmaceuticals (ALNY) shows strong price momentum, hitting new all-time highs on Aug. 11. ALNY has a 100% technical “Bu