Theratechnologies (TSE:TH) has released an update.
Theratechnologies Inc. has received a refusal from the FDA to file its supplemental Biologics License Application for the intramuscular method of Trogarzo, an HIV-1 treatment, citing the application’s lack of necessary data. Despite maintained viral suppression in a recent study, the company faces challenges with this method of administration and is exploring options moving forward. Trogarzo is currently available via intravenous infusion and is specifically indicated for adults with multidrug-resistant HIV-1.
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