Nogapendekin alfa inbakicept-pmln (Anktiva – ImmunityBio), a first-in-class interleukin-15 (IL15) receptor agonist, has been approved by the FDA for use with Bacillus Calmette-Guérin (BCG) for treatment of patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. Such patients generally undergo bladder tumor resection, followed by intravesical BCG treatment, but treatment failure and cancer recurrence are common. The adenoviral vector-based intravesical gene therapy nadofaragene firadenovec-vncg (Adstiladrin)...

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.

Oliceridine (Olinvyk - Trevena), an IV opioid agonist, has been approved by the FDA for management of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate.

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has received an Emergency Use Authorization (EUA) from the FDA for IV treatment of COVID-19 in hospitalized patients ≥2 years old who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab has been approved by the FDA for various indications, including rheumatoid arthritis and juvenile idiopathic arthritis.

The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.

A 2024-2025 formulation of the Novavax adjuvanted protein subunit COVID-19 vaccine that more closely targets currently circulating SARS-CoV-2 variants is available now under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old. The 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were licensed by the FDA last month for use in persons ≥12 years old and made available under EUAs for use in persons 6 months to 11 years old.

An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine in most patients without vascular disease. Treatment of pain when it is still mild to moderate in intensity improves headache response and reduces the risk of recurrence.

Brexucabtagene autoleucel (Tecartus – Kite) has been approved by the FDA for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It was previously approved for treatment of relapsed or refractory mantle cell lymphoma. Tecartus is an individualized cellular product prepared from the patients own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The CAR T-cell immunotherapy tisagenlecleucel (Kymriah) was approved in 2017 for treatment of relapsed or refractory...

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.