The FDA has approved a 6% otic suspension formulation of the fluoroquinolone antibiotic ciprofloxacin (Otiprio – Otonomy) for single-dose treatment of acute otitis externa (swimmer's ear) caused by Pseudomonas aeruginosa or Staphylococcus aureus in patients ≥6 months old. Otiprio was approved earlier for prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement.

The B-lymphocyte stimulator (BLyS)-specific inhibitor belimumab (Benlysta – GSK), which was approved earlier for treatment of active, autoantibody-positive, nonrenal, systemic lupus erythematosus (SLE), has now been approved for use in addition to standard therapy for treatment of active lupus nephritis in adults. Belimumab is the first drug to be approved in the US for treatment of both SLE and lupus nephritis.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

Teclistamab-cqyv (Tecvayli – Janssen), 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 response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. It is also approved to improve glycemic control in patients ≥10 years old with type 2 diabetes, to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with HF, and to reduce the risk of cardiovascular death in adults with type...

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with carboplatin and paclitaxel for first-line treatment of unresectable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as monotherapy in patients who had disease progression or intolerance to platinum-based chemotherapy. The drug received accelerated approval for treatment of recurrent locally advanced or metastatic Merkel cell carcinoma in 2023.

Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also effective in preventing pregnancy. When used alone, barrier and behavioral methods generally have higher failure rates than other methods (see Table 1). Selection of a contraceptive method is usually based on patient-specific factors and personal preference

The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.

The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate. Ruxolitinib (Jakafi) is the only other JAK inhibitor available in the US; it is FDA-approved for treatment of myelofibrosis.

The FDA has approved infliximab-dyyb (Inflectra – Pfizer; marketed as Remsima in some countries), as a biosimilar of the TNF inhibitor infliximab (Remicade). Infliximab-dyyb was approved in the European Union (EU) in 2013 and in Canada in 2014. It is the second biosimilar to be approved by the FDA. Filgastrim-sndz (Zarxio), a recombinant human granulocyte colony-stimulating factor, was the first.