The FDA has approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults with WHO Group 1 pulmonary arterial hypertension (PAH).

The FDA has approved tenofovir alafenamide (Vemlidy – Gilead) for treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It is the first single-drug product containing tenofovir alafenamide (TAF), a prodrug of the nucleotide reverse transcriptase inhibitor tenofovir, to become available; several combination products containing TAF are approved for treatment of HIV-1 infection. Tenofovir disoproxil fumarate (TDF; Viread – Gilead), another tenofovir prodrug, has been used for many years for treatment of chronic HBV infection; a generic...

The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.

Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the FDA to improve glycemic control in adults with type 2 diabetes. It is the fifth SGLT2 inhibitor to be approved in the US for this indication (see Table 4).

Dapagliflozin (dap" a gli fl oe' zin; Farxiga – Bristol-Myers Squibb/AstraZeneca), an SGLT2 (sodium-glucose co-transporter 2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. Dapagliflozin is the second SGLT2 inhibitor to be approved for this indication; canagliflozin (Invokana) was the first .

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

Depression occurs in up to 20% of pregnant women, and the use of selective serotonin reuptake inhibitors (SSRIs) in these women has been increasing. Maternal depression has itself been associated with intrauterine growth problems and low birth weight, so the risks of exposure to antidepressants during pregnancy must be weighed against the risks of untreated depression, which also include self-harm, poor bonding and poor parenting. SSRIs available in the US for treatment of depression include citalopram (Celexa, and others), escitalopram (Lexapro), fluoxetine (Prozac, and others), paroxetine...

An old conjugated estrogens vaginal cream (Premarin Vaginal Cream - Wyeth) has been newly approved by the FDA specifically for treatment of moderate to severe dyspareunia due to vulvar and vaginal atrophy associated with menopause. Synthetic conjugated estrogens A vaginal cream (Barr) has also been approved for this indication, but has not yet been marketed.

The FDA has approved tapentadol hydrochloride (Nucynta - Ortho-McNeil Janssen) for oral treatment of moderate to severe acute pain in patients ≥18 years old. It has been classified as a Schedule II controlled substance

The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta₂-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed for treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients ≥18 years old with asthma. Airsupra is the first combination of a SABA and an ICS to become available in the US. It is not approved for use as maintenance therapy.