STAT+: FDA dings Kaleido Biosciences for testing a microbiome drug without proper paperwork

The Food and Drug Administration is warning Lexington, Mass.-based Kaleido Biosciences that it shouldn’t have tested one of its microbiome therapeutics in humans without filing the paperwork the agency requires to begin clinical trials.

The FDA’s warning letter, published in late August and reported first by Endpoints, focuses only on a microbiome therapeutic that Kaleido was testing as a Covid-19 treatment.

Continue to STAT+ to read the full story…