FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
No Joy in Mudville: Federal Circuit Affirms Aaron Judge and MLBBPA’s Priority in Marks All Rise and Here Comes the Judge Based on Extensive Evidence of Licensed Use
Today, Aaron Judge (“Judge”) is a household name for sports fans across the United States. However, in 2017, Judge was just entering the Major League Baseball scene and carving out...
Knobbe Martens Guides Edwards Lifesciences to Complete Victory in Patent Infringement Dispute
IRVINE, Calif., March 16, 2026 – A team from Knobbe Martens secured a complete defensive victory for Edwards Lifesciences in a patent dispute with Aortic Innovations involving Edwards’ lifesaving transcatheter...
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