FDA committee clears Theratechnologies’ tesamorelin

An FDA advisory committee recommended by a 16-to-0 unanimous vote that Theratechnologies’ (TSX:TH) tesamorelin drug should be granted marketing approval by the FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favourable benefit-risk profile. “This recommendation reinforces our belief that the tesamorelin benefit-risk profile seen in clinical trials [...]