The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
6don MSN
Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
Inovio’s upside hinges on INO-3107 for HPV-6/11 RRP with FDA PDUFA Oct 2026, regulatory risk, tight cash, and cheap EV. Check ...
A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...
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