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.

The FDA has approved Shield (Guardant), a DNA blood test, for colorectal cancer (CRC) screening in average-risk adults ≥45 years old. Shield is the second blood-based DNA test to be approved for CRC screening; ColoHealth (formerly Epi proColon) was approved in 2016.

The FDA has approved Emblaveo (Abbvie), an intravenously administered fixed-dose combination of the monobactam antibacterial drug aztreonam and the beta-lactamase inhibitor avibactam, for use with metronidazole to treat complicated intra-abdominal infections (cIAIs) in adults.

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

Glaucoma is a progressive optic neuropathy associated with increased intraocular pressure (IOP; normal range 8-22 mm Hg), which is the only disease-related factor that can be modified. Topical drugs that lower IOP are the first line of treatment for open-angle glaucoma.

The FDA has expanded its Emergency Use Authorization (EUA) for the COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to permit use of the bivalent formulation (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children 6 months to 4 years old who completed the primary series with 3 doses of the monovalent formulation ≥2 months previously. The Pfizer bivalent vaccine had previously been authorized for use as a booster dose in persons ≥5 years old and as a third primary dose in children 6 months to 4 years old. Booster...

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.

Revakinagene taroretcel-lwey (Encelto – Neurotech), an intravitreal allogeneic cell-based gene therapy, has been approved by the FDA for treatment of idiopathic macular telangiectasia type 2 in adults. It is the first treatment to be approved in the US for this indication.

The FDA has approved Lasix ONYU (SQ Innovation), a subcutaneous formulation of the loop diuretic furosemide administered via a wearable pump (onbody infusor), for treatment of edema in adults with chronic heart failure (HF). A similar product, Furoscix, is approved for treatment of edema in chronic HF or chronic kidney disease. Furosemide has been available for years in oral and IV formulations for such use.

An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine in most patients without vascular disease. Treatment of pain when it is still mild to moderate in intensity improves headache response and reduces the risk of recurrence.