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The FDA has approved Leqembi Iqlik, the subcutaneous (SC) formulation of the amyloid beta-directed monoclonal antibody lecanemab, for once-weekly initiation dosing in patients with Alzheimer's disease (AD). The SC formulation was previously approved only for maintenance treatment in patients who had received IV lecanemab for at least 18 months.

View the Comparison Table: Triptans

View the Comparison Table: Amyloid Beta-Directed Antibodies for Alzheimer's Disease

The FDA has approved the over-the-counter (OTC) sale of Rextovy (Amphastar), a nasal spray formulation of the opioid antagonist naloxone, for emergency treatment of opioid overdose. Other naloxone nasal sprays (Narcan, and generics; RiVive) are also available OTC (see Table 1).

Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

Treatment of migraine headache pain when it is still mild to moderate in intensity improves response and reduces the risk of recurrence. An oral nonopioid analgesic such as a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. When moderate to severe migraine pain is not managed adequately with a nonopioid analgesic alone, addition of a triptan is recommended.

The FDA has licensed mFLUSIVA (Moderna), the first mRNA-based influenza vaccine in the US, for prevention of influenza in adults ≥50 years old. mFLUSIVA will be available for the 2026-2027 influenza season. Three mRNA COVID-19 vaccines (Comirnaty, Spikevax, and mNEXSPIKE) and one mRNA RSV vaccine (mRESVIA) are also licensed in the US.

Enlicitide (Lipfendra – Merck), an oral proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor, has been approved by the FDA to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). It is the first oral PCSK9 inhibitor to be approved in the US; the other FDA-approved PCSK9 inhibitors (alirocumab [Praluent], evolocumab [Repatha], and lerodalcibep [Lerochol]) and the PCSK9-directed small interfering RNA inclisiran (Leqvio) are injected subcutaneously. Lipfendra was approved under the Commissioner's National Priority Voucher program, which accelerates the FDA review process for drugs that align with critical national health priorities.

The FDA has approved Idvynso (Merck), a once-daily fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine and the first-in- class nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir, to replace the current anti-retroviral (ARV) regimen in adults with HIV-1 infection who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. Idvynso is the first two-drug regimen for HIV that does not contain an integrase strand transfer inhibitor (INSTI) or tenofovir. Doravirine is also available alone (Pifeltro) and in combination with lamivudine and tenofovir disoproxil fumarate (Delstrigo).

The FDA has approved olezarsen (Tryngolza – Ionis), a subcutaneously injected apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide, to reduce triglyceride levels and the risk of acute pancreatitis in adults with severe hypertriglyceridemia. Olezarsen and the apoC-III-directed small interfering RNA plozasiran (Redemplo) were approved earlier to reduce triglyceride levels in adults with familial chylomicronemia syndrome (FCS).