The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...

Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

Trofinetide (Daybue – Acadia), a synthetic analog of glycine-proline-glutamate, has been approved by the FDA for treatment of Rett syndrome in patients ≥2 years old. It is the first drug to be approved in the US for treatment of Rett syndrome.

The FDA has approved the intravenously administered beta₁-adrenergic blocker landiolol (Rapiblyk – AOP) for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Esmolol (Brevibloc, and generics), another IV beta blocker, was approved earlier for the same indication.

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.

The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. Repotrectinib is the third oral tyrosine kinase inhibitor to be approved for this indication in the US; crizotinib (Xalkori) and entrectinib (Rozlytrek) were approved earlier.

Fluticasone furoate nasal spray (Veramyst - GSK) is now available for once-daily treatment of seasonal and perennial allergic rhinitis in adults and children ≥2 years old. It is similar to fluticasone propionate nasal spray (Flonase, and others), which is now available generically.

Quetiapine (Seroquel - Zeneca), a dibenzothiazepine derivative, has been approved by the FDA for treatment of schizophrenia and other psychotic disorders. It is a new addition to the 'atypical' antipsychotics, which include olanzapine (Zyprexa - Medical Letter, 39:5, 1997), risperidone (Risperdal) and clozapine (Clozaril). Atypical antipsychotic drugs generally are less likely to cause extrapyramidal symptoms than older drugs such as haloperidol (Haldol, and others) or the phenothiazines.

Clomipramine (Anafranil - Ciba-Geigy), a tricyclic antidepressant, is now available for treatment of obsessive compulsive disorder (OCD) in accordance with the new US Food and Drug Administration (FDA) procedure for promising investigational drugs (FE Young et al, JAMA, 259:2267, 1988). In other countries, clomipramine has been widely used for many years for treatment of depression.

Tolcapone (Tasmar - Roche), a dihydroxy-methyl-nitrobenophenone, has been marketed as an adjunct to levodopa/carbidopa (Sinemet, and others) for treatment of Parkinson's disease in both stable patients and those with end-of-dose "wearing off"of levodopa.