Acarbose (Precose -Bayer), an oral alpha-glucosidase inhibitor that has been available in Europe for several years, was recently approved by the US Food and Drug Administration (FDA) for treatment of non-insulin-dependent diabetes mellitus (NIDDM).

Tiludronate (Skelid - Sanofi), a chloro-4-phenylthiomethylene bisphosphonate, has been approved by the US Food and Drug Administration (FDA) for treatment of Paget's disease of bone. Characterized by excessive bone resorption and disorganized bone remodeling, Paget's disease occurs in up to 3% of people more than 55 years old in Europe and North America (PD Delmas and PJ Meunier, N Engl J Med, 336:558, Feb 20, 1997).

Recent articles in the press have trumpeted a new era in the management of Parkinson's disease: dopamine agonists have now replaced levodopa for initial treatment.

The FDA has approved Descovy (Gilead), a fixed-dose combination of the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine (FTC) and tenofovir alafenamide (TAF) for use with other antiretroviral agents for treatment of HIV-1 infection. A combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF; Truvada) has been available since 2004 for the same indication. Emtricitabine and TAF are also available in combination with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine as Odefsey and with the integrase strand transfer...

The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. Encorafenib was approved in 2018 for use with the mitogen-activated kinase (MEK) inhibitor binimetinib (Mektovi) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a BTK inhibitor. Accelerated approval was based on the response rate. The BTK inhibitors ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) are also approved for treatment of MCL.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

The FDA has approved diazoxide choline extended-release tablets (Vykat XR – Soleno Therapeutics) for treatment of hyperphagia in patients ≥4 years old with Prader-Willi syndrome. Diazoxide choline is the first drug to be approved in the US for this indication. Diazoxide oral suspension (Proglycem) has been available for years for management of symptomatic hypoglycemia.

Levalbuterol, the R-isomer of racemic albuterol, has been approved by the FDA for prevention and treatment of bronchospasm in patients at least 12 years old.