Yutiq (Eyepoint), an intravitreal implant containing the corticosteroid fluocinolone acetonide, has been approved by the FDA for treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. It is the third fluocinolone acetonide intravitreal implant to be approved in the US; Retisert, which is approved for the same indication as Yutiq, and Iluvien, which is approved for treatment of diabetic macular edema, were approved earlier. A dexamethasone intravitreal implant (Ozurdex) is approved by the FDA for treatment of noninfectious uveitis and macular...

Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.

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.

A reader of our article on the 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) asked us to provide more information on the data that supported their licensure.

Annual vaccination in the US against influenza A and B viruses is recommended for everyone ≥6 months old without a contraindication. Influenza vaccines available in the US for the 2024-2025 season are listed in Table 2.

On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.

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.

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.

View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis