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The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.

The short-acting formulation of mixed amphetamine salts (Adderall, and generics) FDA-approved for treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently in short supply in the US. Until an adequate supply is restored, patients may be looking for alternatives.

Age-related macular degeneration (AMD) has two major forms: dry or non-neovascular (~90% of patients) and wet or neovascular (~10% of patients).

Vyalev (Abbvie), a solution for continuous subcutaneous infusion containing the prodrugs foscarbidopa and foslevodopa, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Vyalev is the first subcutaneously administered product to become available in the US for treatment of PD symptoms. Duopa, a carbidopa/levodopa enteral suspension infused via a nasojejunal tube or percutaneous gastrostomy, was approved in for the same indication 2015.

Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A gene (KMT2A) translocation. It is the first menin inhibitor to be approved in the US.

The FDA has approved pilocarpine 0.4% preservativefree ophthalmic solution (Qlosi – Orasis) for treatment of presbyopia in adults. Pilocarpine 1.25% ophthalmic solution (Vuity) was approved in 2021 for the same indication. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local (e.g., blurry vision and instillation-site pain) and systemic (e.g., sweating and GI disturbances) adverse effects have limited their use.

Topical ivermectin lotion 0.5% (Sklice, and generics), which has been available by prescription since 2012, is now FDA-approved for sale over the counter (OTC) for treatment of head lice in patients ≥6 months old. Ivermectin is also available by prescription as a 1% cream (Soolantra) approved for topical treatment of inflammatory lesions of rosacea and in oral tablets (Stromectol, and generics) for treatment of various parasitic infections.

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.

The FDA has licensed Capvaxive (PCV21; Merck), a 21-valent pneumococcal conjugate vaccine, for prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults. Four other pneumococcal vaccines are currently available in the US: Prevnar 20 (PCV20), Vaxneuvance (PCV15), and Prevnar 13 (PCV13) are conjugate vaccines licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23) is a pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years old (see Table 1).

The FDA has authorized use of the Valeda Light Delivery System (LumiThera), a multiwavelength photobiomodulation (PBM) device, to improve visual acuity in patients with dry age-related macular degeneration (AMD) who have best-corrected visual acuity (BCVA) of 20/32 to 20/70.