The FDA has approved a subcutaneous formulation of the recombinant human anti-CD20 antibody ofatumumab (Kesimpta – Novartis) for 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). Kesimpta is the second anti-CD20 antibody to be approved for these indications; IV ocrelizumab (Ocrevus), which is also approved for treatment of primary progressive MS, was the first. An IV formulation of ofatumumab (Arzerra) has...

The FDA has approved Fortesta (Endo), a topical gel, for testosterone replacement therapy in adult males with hypogonadism. It is classified as a Schedule III controlled substance. Table 1 lists some available testosterone products, including 2 other gels.

Efbemalenograstim alfa-vuxw (Ryzneuta – Evive), a nonpegylated granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG2, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia. It is the first nonpegylated, long-acting G-CSF to become available in the US. Two pegylated, long-acting G-CSFs, pegfilgrastim (Neulasta, and biosimilars) and eflapegrastim (Rolvedon), are...

The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic agent (LAMA) administered once daily by standard jet nebulizer, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is the second nebulized LAMA to be approved for this indication; glycopyrrolate (Lonhala Magnair), which is administered twice daily with a portable handheld nebulizer, was the first.

Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It is the first drug to be approved for treatment of generalized myasthenia gravis in patients with anti-MuSK antibodies. Four other biologic drugs – the FcRn blocker efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) and the complement inhibitors eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – are...

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.

Ophthalmic formulations of ketotifen fumarate (Zaditor), pemirolast potassium (Alamast) and nedocromil sodium (Alocril) have recently been approved by the FDA for use in adults and children with itching of the eyes due to allergic conjunctivitis.

BCG Live (TheraCys - Connaught) and BCG Vaccine U.S.P. (TiceBCG - Organon), freeze-dried suspensions of an attenuated strain of Mycobacterium bovis, were recently approved by the US Food and Drug Administration for intravesical treatment of primary or relapsed carcinoma in situ of the bladder, with or without associated papillary tumors. BCG is not recommended for treatment of papillary tumors occurring alone.

Talquetamab-tgvs (Talvey – Janssen), a bispecific GPRC5D-directed 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. Talquetamab is the first bispecific GPRC5D-directed T-cell engager to be approved in the US

The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children ≤24 months old who are at increased risk for severe RSV disease through their second RSV season. Nirsevimab is the first drug to be approved for protection of all infants during their first RSV season.