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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).

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.

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

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.

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment could also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

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The FDA has licensed new 2025-2026 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax, mNEXSPIKE) and the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax (Nuvaxovid). The new formulations are indicated for use in all adults ≥65 years old and in persons 6 months (Spikevax), 5 years (Comirnaty), or 12 years (mNEXSPIKE, Nuvaxovid) through 64 years old who are at high risk for severe COVID-19 because of an underlying condition. An Emergency Use Authorization allowing administration of the Pfizer vaccine to children 6 months through 4 years old has been withdrawn.