The FDA has approved ganaxolone (Ztalmy – Marinus) for oral treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in patients ≥2 years old. It is the first drug to be approved in the US for this indication.

The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to be approved in the US for this indication and the first oral nonopioid drug to be approved for treatment of pain in over 25 years.

Myocardial images produced by injections of radioactive thallium chloride (201Tl), usually during exercise, have been used for many years for diagnosis of coronary artery disease (Medical Letter, 21:49, 1979). Recently, some new techniques and radiopharmaceuticals have become available for myocardial imaging.

Diagnostic tests for human immunodeficiency virus (HIV) infection use four approaches: identification of antibodies to viral proteins, detection of viral antigens, detection of viral nucleic acids, and culturing the virus (CJ Schleupner in GL Mandell et al, eds, Principles and Practice of Infectious Diseases, 4th ed, New York:Churchill Livingstone, 1995, page 1253). In recent years, the FDA has approved the use of a 10- minute blood test, two home collection kits, and office tests that use urine and oral secretions to diagnose HIV infection. One home test, Confide (Johnson & Johnson), was...

The FDA has approved the prostaglandin analog bimatoprost in a 0.03% solution (Latisse - Allergan) for increasing eyelash length, thickness and darkness in patients with hypotrichosis of the eyelashes.

Canagliflozin (kan" a gli floe' zin; Invokana – Janssen), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes.

The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death. The FDA previously issued warnings about these drugs in 2013 and 2015.

The FDA has approved voretigene neparvovec-rzyl intraocular suspension (Luxturna – Spark), an adeno-associated virus vector-based gene therapy, for treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy in patients who have viable retinal cells. It is the first gene replacement therapy approved in the US that targets a disease caused by mutations in a specific gene and the first pharmacologic treatment to be approved for this disorder.

The FDA has approved brigatinib (Alunbrig – Takeda), an oral tyrosine kinase inhibitor, for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma. Brigatinib is the third tyrosine kinase inhibitor to be approved for this indication; ceritinib (Zykadia) and alectinib (Alecensa) were approved earlier, and subsequently were...

The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.