BioPharma Dive November 21, 2025
BioPharma Dive staff

The FDA will now allow biotechs to ask agency staff for “quick clarifications” via email. Elsewhere, Novartis hiked guidance for two drugs and a startup nearing “unicorn” status secured a megaround.

Today, a brief rundown of news from The Food and Drug Administration and Profluent, as well as updates from Novartis, Innovent Biologics and Flagship Pioneering that you may have missed.

The Food and Drug Administration announced a new pilot program intended to speed up communications with drugmakers following formal meetings. The new program allows companies the opportunity after a meeting to submit an email question to agency staff asking for a “quick clarification” regarding a specific issue. The FDA then aims to respond within three business days. The pilot...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Investments, Technology, Trends
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