FDA approves smallpox drug under Animal Rule

2021-06-09

The FDA approved Tembexa, or brincidofovir, by Chimerix, for smallpox using the Animal Rule, which allows the agency to approve needed drugs when studies in humans are not possible. The drug is also being studied for cytomegalovirus and adenovirus infections associated with bone marrow transplantation, and those studies were used to demonstrate the drug's safety.

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