The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether...

The FDA has approved the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris – Seattle Genetics) for use in combination with chemotherapy for IV treatment of adults with previously untreated stage 3 or 4 classical Hodgkin's lymphoma (cHL). Adcetris was approved earlier for consolidation treatment of cHL and for treatment of relapsed or refractory cHL, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.FDA approval for the new indication was based on the results of an open-label trial (ECHELON-1) in 1334 patients with previously untreated stage 3 or 4 cHL.1...

On May 10, 2021, the FDA expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine to include adolescents 12-15 years old.1The vaccine has been authorized for use in persons ≥16 years old since December 2020.

On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.

Recently published guidelines recommend screening patients with hypertension for primary aldosteronism. The Endocrine Society recommends screening all patients and the American College of Cardiology/American Heart Association (ACC/AHA) recommend screening those at increased risk (see Table 1).

A live attenuated varicella vaccine (Varivax - Merck) has been approved for marketing by the US Food and Drug Administration. The Oka/Merck strain used in the vaccine is attenuated by passage in human and embryonic guinea pig cell cultures.

Recombinant interferon alfa-2b conjugated to polyethylene glycol (PEG-Intron), the first "pegylated"alpha interferon, has been approved by the FDA for once-a-week monotherapy of chronic hepatitis C virus (HCV) infection in patients not previously treated with alpha interferon.

Echinacea, a plant also called purple coneflower, is widely used as a dietary supplement for prevention and treatment of colds.

A new pentavalent vaccine (Pediarix - GlaxoSmithKline), licensed by the FDA for children 6 weeks to 7 years old, includes the antigens from vaccines already marketed against diphtheria, tetanus and pertussis (Infanrix) and hepatitis B (Engerix-B), and a new inactivated polio component.

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