Tirbanibulin, a microtubule inhibitor, has been approved by the FDA as a 1% ointment (Klisyri – Almirall) for topical treatment of actinic keratosis of the face or scalp.

The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use as monotherapy or as an adjunct to lithium or valproate for treatment of depressive episodes associated with bipolar I or II disorder in adults.

IV antiviral drug remdesivir (Veklury) has now been FDA-approved for treatment of COVID-19 in patients ≥28 days old who weigh ≥3 kg and are either hospitalized or at high risk for progression to severe disease. Remdesivir was already FDA-approved for these indications in patients ≥12 years old who weigh ≥40 kg; it was available under an Emergency Use Authorization (EUA) for younger or lighter patients. Remdesivir is the first drug to be FDA-approved for treatment of COVID-19 in children <12 years old.

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.

View the Comparison Chart: GLP-1 and GIP/GLP-1 Receptor Agonists for Type 2 Diabetes

The FDA has approved an oral tablet formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) for chronic weight management in adults. It is the first oral GLP-1 receptor agonist to be approved in the US for weight management. An injectable formulation of Wegovy was approved for the same indication in 2021.1 The injectable GLP-1 receptor agonist liraglutide (Saxenda, and generic) and the injectable glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Zepbound) are also FDA-approved for chronic weight management (see...

The FDA has approved the nitrofuran antiprotozoal drug nifurtimox (Lampit – Bayer) for treatment of Chagas disease (American trypanosomiasis) in children who weigh ≥2.5 kg. Nifurtimox was previously available in the US only through a CDC-sponsored Investigational New Drug (IND) program.

Nonopioid drugs can be used in the treatment of many nociceptive and neuropathic pain conditions. For severe pain, especially severe chronic cancer pain, use of opioids may be necessary. Noninvasive nonpharmacologic treatments, including physical and psychological therapies, have been shown to improve pain and function in patients with some common chronic pain conditions and are unlikely to cause serious harms. A multimodal approach to analgesic therapy can increase pain control while reducing opioid use and adverse effects.

The FDA has approved Crexont (Amneal), an extended-release capsule formulation of carbidopa/levodopa, for treatment of Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism associated with carbon monoxide or manganese intoxication. Crexont contains a combination of immediate-release carbidopa/levodopa granules and extended-release levodopa pellets. An extended-release carbidopa/levodopa oral capsule (Rytary) has been available from the same manufacturer for years; the patent for Rytary expires in 2025.

The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.