Pneumonia, candidiasis and more: The non-vaccine approvals of 2023
The FDA in 2023 approved treatments for several hospital-associated infections and fully approved a long-used COVID-19 medication, among other non-vaccine-related regulatory decisions.
Here are some treatment approvals you may have missed in 2023.
FDA approves Paxlovid as treatment for adults at high risk for severe COVID-19
Initially granted an emergency use authorization in December 2021, Paxlovid was granted full approval for treatment of mild-to-moderate COVID-19 based on data from three phase 2/3 trials. Read more.
FDA approves new treatment for nosocomial pneumonia
IV sulbactam-durlobactam is the “first effective, safe option” to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by drug-resistant strains of Acinetobacter baumanii-calcoaceticus complex. Read more.
FDA-approved microbiome therapy reduces recurrent CDI, regardless of risk factors
Vowst, an oral fecal microbiome therapy, received approval in April for patients at high-risk for recurrent Clostridioides difficile infection regardless of demographics or baseline risk factors. Read more.
FDA approves new treatment for candidemia, invasive candidiasis
With the approval of the once-weekly injection Rezzzayo in March, physicians had their first new therapy in a decade for candidemia and invasive candidiasis. Read more.
Vaginal ring for HIV prevention authorized in 11 African nations
The dapivirine-releasing flexible ring has been licensed for use in 11 African nations and is available in six of them through implementation and pilot studies. With a manufacturing license awarded for local production, patients costs for the ring are expected to down. Read more.