Mibefradil dihydrochloride (Posicor - Roche), a chemically distinct nondihydropyridine calcium-channel blocker, has been approved by the US Food and Drug Administration (FDA) and is being heavily promoted as the first T-type calcium-channel blocker for treatment of hypertension and chronic stable angina.

The FDA has approved secnidazole oral granules (Solosec – Symbiomix/Lupin) for single-dose treatment of bacterial vaginosis (BV) in adult women.

The FDA has approved the use of recombinant human antithrombin (rhAT; ATryn - Lundbeck) in patients with inherited antithrombin (AT) deficiency to prevent thrombosis during or after surgery or childbirth. The protein is produced in the milk of transgenic goats carrying a copy of the human cDNA for AT. This is the first US drug approval for a protein produced by a transgenic animal. ATryn has been used in Europe since 2006.

The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It is also used off-label to treat pericarditis, and in recent years has been investigated for reduction of cardiovascular risk in patients with coronary artery disease (CAD).

Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved in the US for this indication. Tacrolimus (Prograf, and others) and cyclosporine (Neoral, and others), the other available systemic calcineurin inhibitors, are approved for prophylaxis of organ rejection in transplant patients.

Elranatamab-bcmm (Elrexfio – Pfizer), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on the response rate and durability of response. Elranatamab is the second bispecific BCMA-directed CD3 T-cell engager to be approved for this indication; teclistamab (Tecvayli) was the...

The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First approved in 2009 for treatment of schizophrenia, iloperidone is the eighth second-generation antipsychotic to be approved for acute treatment of manic or mixed episodes of bipolar I disorder (see Table 1).

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight management in children ≥12 years old with an initial BMI in the ≥95th percentile for age and sex.Semaglutide is also available as Ozempic and Rybelsus for treatment of type 2 diabetes in adults.

Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in adults who received ≥2 lines of systemic therapy. It is the first T-cell-engaging bispecific antibody to be approved in the US for this indication.

The FDA has approved vemurafenib (Zelboraf – Genentech), a kinase inhibitor, for treatment of unresectable or metastatic melanoma with the BRAF V600E mutation, which is found in 30-60% of melanomas. An FDA-approved test can detect the mutation in DNA from melanoma tissue.