Cosibelimab (Unloxcyt – Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, has been approved by the FDA for treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in adults who are not candidates for curative surgery or radiation. It is the first PD-L1 inhibitor to be approved in the US for this indication. The PD-1 inhibitors pembrolizumab (Keytruda) and cemiplimab (Libtayo) are also approved for treatment of cutaneous squamous cell carcinoma.

In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical...

The FDA has approved a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase (Phesgo – Genentech) for use in combination with chemotherapy for neoadjuvant (preoperative) treatment of human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early-stage breast cancer, or for adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence, or with docetaxel for treatment of those with HER2-positive metastatic breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic disease....

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...

Afamitresgene autoleucel (Tecelra – Adaptimmune), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy and are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. It is the first gene therapy to be approved in the US for treatment of synovial sarcoma. Accelerated approval of the immunotherapy was based on the...

The FDA has licensed mNEXSPIKE (Moderna), an mRNA vaccine, for prevention of COVID-19 in adults ≥65 years old and in persons 12-64 years old who have a condition that puts them at high risk for severe outcomes from COVID-19. Spikevax, the original Moderna mRNA COVID-19 vaccine, remains in production2; it is licensed for use in persons ≥12 years old and is available under an Emergency Use Authorization (EUA) for children 6 months to 11 years old.

The FDA has licensed Penbraya (Pfizer), a pentavalent polysaccharide conjugate meningococcal vaccine, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penbraya is the only meningococcal vaccine that contains all five of these serogroups. Two quadrivalent polysaccharide conjugate meningococcal vaccines containing serogroups A, C, W, and Y (MenACWY; Menveo, MenQuadfi) and two meningococcal serogroup B vaccines (MenB; Bexsero, Trumenba) are available in the US (see Table...

The FDA has licensed the pentavalent vaccine Penmenvy (GSK) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penmenvy is the second pentavalent meningococcal vaccine to become available in the US; Penbraya was licensed in 2023.

The short-acting beta2-agonist albuterol sulfate has recently become available as a large-volume (20 mL), preservative-free concentrate (albuterol inhalation solution 0.5% – Nephron Pharmaceuticals) that can be used to prepare solutions for administration of continuous nebulized albuterol (CNA). CNA is commonly used (off-label) for acute treatment of severe asthma exacerbations in hospitalized patients, particularly children. Many hospitals have been using a 20-mL multidose bottle of 0.5% albuterol that contains the preservative benzalkonium chloride (BAC) for this purpose. Until...

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a third dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18 years old (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent (see Table 1).