The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

View the Comparison Table: Some Oral Anticoagulants for VTE

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

View Table 3: Some Drug Interactions with DAAs for HCV Infection