The FDA has approved the complement factor B inhibitor iptacopan (Fabhalta – Novartis) for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. Iptacopan is the first oral drug to be approved in the US for this indication. Three parenterally administered drugs, the complement C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris) and the complement C3 inhibitor pegcetacoplan (Empaveli), are also approved for treatment of PNH.

The FDA has authorized use of the Visby Medical Women's Sexual Health Test (Visby), an at-home test available without a prescription, for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections in women with and without symptoms. It is the first test to become available in the US for these sexually transmitted infections (STIs) that can be performed entirely at home. Other at-home tests are available in the US for diagnosis of chlamydia, gonorrhea, and trichomoniaisis, but they require mailing a urine or blood sample to a...

View the Table: Some Drugs for Inflammatory Bowel Disease

Isatuximab-irfc (Sarclisa – Sanofi), a CD38-directed cytolytic antibody, has been approved by the FDA for treatment of newly diagnosed multiple myeloma in adults who are not eligible for autologous stem cell transplantation (ASCT). The drug was approved earlier for treatment of relapsed or treatment-refractory multiple myeloma.

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.

The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It has been available in Israel since 2000.

The FDA has approved omidubicel-onlv (Omisirge – Gamida Cell), a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from cord blood, to reduce the time to neutrophil recovery and the risk of infection in patients ≥12 years old with hematologic malignancies who will undergo umbilical cord blood transplantation following myeloablative conditioning therapy. Hematopoietic progenitor cell (HPC) umbilical cord products (e.g., Allocord, Clevecord, Ducord) have been available in the US for years for the same indication. Cord blood banks also supply cord...

Gastroesophageal reflux disease (GERD) is the most common GI condition encountered in the outpatient setting; it affects about 20% of people in the US.

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Zilucoplan is the first complement inhibitor to be approved for treatment of myasthenia gravis that can be self-administered. Two IV complement inhibitors, eculizumab (Soliris) and ravulizumab (Ultomiris), were approved earlier.