ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
A phase 3 trial evaluating an investigational antiviral antibody cocktail, REGN-COV2, for the prevention of COVID-19 has been initiated by Regeneron Pharmaceuticals.
The FDA has revoked the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate based on emerging data suggesting that these agents are unlikely to be effective against COVID-19.
Specifically, unacceptable levels of this potentially carcinogenic impurity have been identified in products manufactured by 5 different firms.
The FDA has approved Artesunate for Injection (Amivas) for the initial treatment of severe malaria in adult and pediatric patients.
The vaccine candidate is currently in preclinical development with clinical studies expected to begin later this year.
The FDA has launched a new webpage with information for recovered individuals who were infected with coronavirus disease 2019 (COVID-19) on where they can go to donate plasma to aid in the treatment of severely ill patients.
The Agency is warning the public that the use of these agents should be limited to clinical trial settings or for treating certain hospitalized patients under the Emergency Use Authorization.
The Food and Drug Administration (FDA) has expanded the approval of Cymbalta (duloxetine; Lilly) to include treatment of fibromyalgia in pediatric patients 13 to 17 years of age.
Currently, there are no approved treatments for COVID-19, however, several investigational therapies are in the works.
