Vilobelimab, marketed under the brand name Gohibic, has been authorized by the FDA for emergency use but has not yet received full FDA approval for the treatment of COVID-19.

It received approval on March 24, 2023, for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in individuals aged 12 years and older.

Retifanlimab, marketed under the brand name Zynyz, was approved by the FDA on March 22, 2023.

Rezafungin, marketed under the brand name Rezzayo, was approved by the FDA on March 22, 2023.

The FDA approved Daybue on March 10, 2023, for the treatment of Rett syndrome in adults and children aged 2 years and older.

The FDA approved Skyclarys on February 28, 2023, for the treatment of Friedreich's ataxia in adults and teenagers 16 years and older.

The FDA approved Prevduo for use in adults and children at least 2 years old to help regain muscle function after surgery.

The FDA granted approval to Altuviiio as a first-in-class, high-sustained factor VIII replacement therapy for hemophilia A patients on February 22, 2023.

The FDA granted accelerated approval to Sparsentan for its ability to reduce proteinuria (excess protein in the urine) in adults with primary immunoglobulin A nephropathy.

Pirtobrutinib, marketed under the brand name Jaypirca, is FDA approved. The FDA granted accelerated approval to Pirtobrutinib on January 27, 2023.

Elacestrant was approved by the FDA on January 27, 2023, for the treatment of advanced or metastatic breast cancer in postmenopausal women and adult men.

The FDA approved Bexagliflozin under the brand name Brenzavvy on January 20, 2023.