We have to distinguish between a drug with two modes of action and a drug with two separate active ingredients. From a regulatory standpoint, the former are regulated just like any other drug regardless of whether they are small molecules or biologics.
The latter typically have to show that they are superior to each constituent ingredient individually, which makes the clinical trials required for approval more complex.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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