The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It has been available in Israel since 2000.

FluMist (AstraZeneca), the live-attenuated intranasal influenza vaccine that has been available for years for administration by a healthcare provider in nonpregnant persons 2-49 years old, has now been approved by the FDA for self- or caregiver-administration. It is expected to be available for such use during the 2025-2026 influenza season. FluMist is only available through a healthcare provider this season. It will continue to be available for administration by a healthcare provider in the future

Recently published guidelines from the American Diabetes Association (ADA) and the Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group recommend addition of the oral nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone (Kerendia) to standard treatment in patients with type 2 diabetes and chronic kidney disease (CKD).

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).

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...

The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for use in children 2-17 years old hospitalized with COVID-19 who require oxygen support.

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.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

Plenity (Gelesis), a nonsystemic oral superabsorbent hydrogel formulation of cellulose and citric acid is now available. It was cleared by the FDA in 2019 to aid in weight management together with diet and exercise in overweight and obese adults (BMI of 25-40 kg/m2). It is classified by the FDA as a device because the contents of the capsule are not absorbed systemically. Plenity is the first ingested, transient, space-occupying hydrogel to be marketed in the US and the only weight management treatment available by prescription for patients with a BMI of 25-30 kg/m2, regardless of...

Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the...