The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical ...
In early March 2026, the U.S. Food and Drug Administration (FDA) issued updates to its Q&A guidance interpreting and implementing the Biologics ...
* FDA wants animal data showing drug batches work similarly * Lilly says same data may support lung, head & neck filings * Shares of Lilly down 4 percent By Ransdell Pierson NEW YORK, March 2 (Reuters ...
FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved ...
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to ...
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