Dolasetron (Anzemet - Hoechst Marion Roussel), a selective serotonin (5-HT3) receptor antagonist similar to ondansetron (Zofran) and granisetron (Kytril - Medical Letter, 36:61, 1994) is now available for both oral and intravenous use in prevention of nausea and vomiting due to cancer chemotherapy. A 5-HT3 antagonist plus dexamethasone (Decadron, and others) is the most effective regimen for prevention of acute vomiting caused by cancer chemotherapy. Dolasetron has also been approved by the FDA for prevention and treatment of postoperative nausea and...

Extracts made from leaves of the ginkgo tree (Ginkgo biloba) are available in the uSA as deitary supplements, in France and Germany as licensed drugs and worldwide as herbal remedies for treatment of dementia and many other indications.

Prosorba, an antibody-adsorbing column used with plasmapheresis, has been approved by the FDA for treatment of moderate-to-severe rheumatoid arthritis in patients refractory or intolerant to methotrexate and other disease-modifying anti-rheumatic drugs (DMARDs).

Doconsanol 10% cream, a long-chain saturated alcohol, has been approved by the FDA for over-the-counter treatment of herpes labialis.

The CDC has reported that many states are experiencing a higher-than-usual incidence of pertussis this year. The highest incidence has been in infants, but the disease has also occurred in older children, adolescents, and adults. Thirteen pertussis-related deaths were reported through August 24; the majority of these were in infants <3 months old.

Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.

The FDA has approved Diclegis (Duchesnay), a fixed-dose, delayed-release combination of the H1-antihistamine doxylamine and the vitamin B6 analog pyridoxine, for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. It is only available by prescription. Doxylamine and pyridoxine, both currently available over the counter, were previously available by prescription in a fixed-dose combination (Bendectin) for morning sickness. Bendectin was voluntarily withdrawn in the US in 1983 because of claims of teratogenicity that have since been...

Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive factor IX prophylaxis therapy or have had life-threatening or repeated, serious, spontaneous bleeding episodes. It is the first gene therapy to be approved in the US for this indication.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion in adults who had disease progression on or after prior systemic therapy. It is the first drug to be approved in the US for treatment of NRG1-positive cancers. Accelerated approval of zenocutuzumab was based on the overall response rate and duration of response.