New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Key Takeaway: New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare...
AI and Genomics: A New Era of Personalized Medicine
Key Takeaway: Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions. Genomic...
Staking Claims Among the Stars: Patent Protection in the New Space Economy
Key Takeaway: Due to the lower barrier to entry to space, companies that file patents in this developing field now will not only protect their investments but secure an early,...