In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical...

The 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years old. Opzelura is the first product to be approved by the FDA for this indication. It was previously approved for treatment of atopic dermatitis.

Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause worsening functional limitation or severe morbidity. The kinase inhibitor pexidartinib (Turalio) was approved for a similar indication in 2019.

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have been approved by the FDA for use together for a sixth indication: treatment of low-grade glioma (LGG) with a BRAF V600E mutation in patients ≥1 years old who require systemic therapy. This combination is the first systemic therapy to be approved in the US for first-line treatment of LGG with a BRAF V600E mutation in pediatric patients. The FDA also approved new oral formulations of both drugs for patients who are unable to swallow dabrafenib capsules or trametinib...

The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. Injectable testosterone cypionate has been available in multidose vials (Depo-Testosterone, and generics) for many years. Testosterone enanthate (Xyosted) is available in prefilled autoinjectors for use in adult men. No testosterone products are approved for treatment of low testosterone levels due solely to aging. All...

View the Comparison Table: Some Oral Anticoagulants for VTE

The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is the second HIF-PHI to be approved in the US for this indication; daprodustat (Jesduvroq) was approved earlier, but it was withdrawn from the US market in 2024 for commercial reasons.

View the Comparison Table: Some Parenteral Anticoagulants for VTE

About 60% of men ≥60 years old have clinically relevant prostatic enlargement due to benign prostatic hyperplasia (BPH). The goals of treatment are to decrease lower urinary tract symptoms and to prevent disease progression and complications such as acute urinary retention. The American Urologic Association's guidelines for treatment of BPH were recently updated.

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.