The US FDA has approved use of palivizumab for prevention of respiratory syncytial virus (RSV) infection in high-risk infants and children.

The FDA has approved injection of onabotulinumtoxinA (Botox – Allergan) for prevention of headaches in adult patients with chronic migraine (≥15 headache days/month for ≥3 months). It is the first drug approved for treatment of this indication. Botox is also FDA-approved for treatment of upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm and strabismus, and for cosmetic reduction of wrinkles.

Atezolizumab (Tecentriq – Genentech), an immune checkpoint inhibitor, has been approved by the FDA for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients ≥2 years old. It was previously approved for treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular cancer, and melanoma (see Table 1). Atezolizumab is the first drug to be approved in the US for treatment of ASPS. ASPS is a rare disorder that affects mostly adolescents and young adults; <1% of soft tissue sarcomas are ASPS.

Rifabutin (formerly ansamycin; Mycobutin - Adria), a rifamycin antibiotic similar to rifampin (Rifadin, Rimactane) was recently approved by the US Food and Drug Administration for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Immune-mediated hemolysis is a rare adverse effect of second- and third-generation cephalosporins, especially cefotetan (Cefotan) (PA Arndt et al, Transfusion 1999; 39:1239). A recent report serves as a reminder that life-threatening immune-mediated hemolysis rarely can follow administration of ceftriaxone (Rocephin), one of the most commonly used parenteral antibiotics in the US (A Citak et al, J Paediatr Child Health 2002; 38:209).

The FDA has approved carfilzomib (Kyprolis – Onyx), a proteasome inhibitor, for intravenous treatment of refractory multiple myeloma. Bortezomib (Velcade) was the first proteasome inhibitor to be approved for this indication.

The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a BTK inhibitor. Accelerated approval was based on the response rate. The BTK inhibitors ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) are also approved for treatment of MCL.

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

A combination of the corticosteroid budesonide and the long-acting beta₂-agonist formoterol (Symbicort - AstraZeneca) has become available in a metered dose inhaler for long-term maintenance treatment of asthma in patients ≥ 12 years old. A combination product that contains fluticasone propionate and salmeterol (Advair) is already available for this indication in the US. Neither one of these combinations is approved for acute treatment of asthma symptoms. A dry powder inhaler formulation of Symbicort has been available in Europe and Canada for several years.

HA-1A (Centoxin - Centocor), a monoclonal IgM antibody against endotoxin from gram-negative bacteria, may soon be approved for marketing by the US Food and Drug Administration. Commercially available in Europe, HA-1A has been used in the USA as an investigational drug. E5 (Xomen - Xoma), another monoclonal IgM antibody against endotoxin, is also available here for investigational use.