FDA To Review Teva and Alvotech Drug That Could Compete With Regeneron's Eylea
Key Takeaways Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review ...
This Company Just Initiated a Quarterly Dividend: Time to Buy?
Regeneron initiated a quarterly dividend per share that looks somewhat attractive. Despite some recent issues, the biotech ...
Teva and Alvotech get FDA review acceptance for its proposed biosimilar to Eylea
Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...
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FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
In addition to AVT06, which is a biosimilar candidate for Eylea ® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea ® HD (aflibercept) 8 mg. Teva also ...
Regeneron Gets Appeals Court to Impose Tougher Kickback Standard
Regeneron Pharmaceuticals Inc. convinced the First Circuit to impose a higher causation standard in the government’s False Claims Act case alleging a drug kickback scheme, according to a Tuesday ...
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FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...
American Century Focused Dynamic Growth Fund Q4 2024 Commentary
The reelection of former President Donald Trump initially pleased investors who had worried about another protracted legal ...
Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only ...
Regeneron Pharmaceuticals, Inc.: Dupixent (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP)
If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results demonstrat ...