- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
FDA extended PDUFA goal date for PYRUKYND and Agios submitted REMS to mitigate hepatocellular injury risk.
2 reports, 2 independent
Updated Sep 4
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New informationRepeats or wire copies
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What happened
FDA extended PDUFA goal date for PYRUKYND and Agios submitted REMS to mitigate hepatocellular injury risk.
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
- FDA
-
Agios Pharmaceuticals
a public American pharmaceutical company
Coverage
Newest first; wire copies grouped- GlobeNewswireAgios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in Thalassemia PDUFA goal date extended by three months from September 7, 2025, to December 7, 2025 CAMBRIDGE, Mass., Sept. 04,
- Insider MonkeyAgios Pharmaceuticals, Inc. (AGIO) Advances Pipeline With Tebapivat, AG-236 in Rare Blood Disorders We recently compiled a list of the 11 Cheap Biotech Stocks to Buy According to Hedge Funds. Agios P