The FDA has approved obiltoxaximab (Anthim – Elusys Therapeutics), a toxin-targeting monoclonal antibody, for treatment of inhalational anthrax in combination with antibacterial drugs and prophylaxis of inhalational anthrax when other therapies are unavailable or inappropriate. Raxibacumab, another monoclonal antibody, was approved earlier for the same indication. Like raxibacumab, obiltoxaximab is being manufactured only for the CDC national stockpile and is not available for commercial sale.

Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.

Lecanemab-irmb (Leqembi – Eisai/Biogen), the IV amyloid-directed monoclonal antibody that received accelerated approval from the FDA in January 2023 for treatment of early Alzheimer's disease, has now received full approval from the FDA based on a trial showing that it slowed cognitive and functional decline in patients with mild cognitive impairment (MCI) or mild Alzheimer's disease dementia and confirmed presence of brain amyloid. The IV amyloid-directed monoclonal antibody aducanumab (Aduhelm) has received only an accelerated FDA-approval for the same indication.

Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

Marstacimab-hncq (Hympavzi – Pfizer), a tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. It is the first hemophilia treatment to be approved in the US that targets an inhibitor of coagulation and the first to become available in prefilled pens and syringes for subcutaneous administration.

Onapgo (Supernus), a solution for continuous subcutaneous infusion containing the dopamine agonist apomorphine, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Subcutaneously injected apomorphine (Apokyn, and generics) has been available for intermittent use for years. Vyalev, a foscarbidopa/foslevodopa solution for subcutaneous infusion, was approved in 2024 for the same indication.

An IV formulation of pantoprazole sodium (Protonix IV - Wyeth-Ayerst), a benzimidazole proton pump inhibitor (PPI), has been approved by the FDA for short-term treatment of Zollinger-Ellison Syndrome (ZES) and gastroesophageal reflux disease (GERD) in patients who cannot take oral drugs. Pantoprazole is the first PPI to be approved for IV use in the US.

Zolmitriptan (Zomig - AstraZeneca) nasal spray was recently approved by the FDA for treatment of migraine. It is the second selective serotonin receptor agonist ("triptan") to become available as a nasal spray; sumatriptan has been available in this form since 1997. Some patients with migraine cannot take tablets because of nausea and vomiting, and nasal sprays are more convenient than subcutaneous injections.

Some patients with primary immune deficiency are injected with intravenous immune globulin (IVIG) every 3-4 weeks. Now a subcutaneous immune globulin (SCIG) has also been approved in the US for this indication (Vivaglobin - CSL Behring). SCIG has been used in Europe for about 10 years.

The EarCheck Middle Ear Monitor (Innovia Medical) is a device marketed to consumers for home detection of middle-ear effusion (MEE) in children.