The FDA has approved the use of the oral multikinase inhibitor sorafenib (Nexavar – Bayer) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment. Sorafenib was approved earlier for treatment of advanced renal cell and unresectable hepatocellular cancer.

On April 23, 2021, on advice from the Advisory Committee on Immunization Practices (ACIP), the FDA and CDC recommended that use of the Johnson & Johnson adenovirus-based COVID-19 vaccine resume despite its association with development of thrombosis with thrombocytopenia syndrome (TTS). Administration of the vaccine had been paused on April 13 because of 6 reports of TTS, but after completing a data review that identified a further 9 cases associated with the formulation, the agencies concluded that the benefits of the vaccine outweighed its risks. About 7.98 million doses of the...

Revakinagene taroretcel-lwey (Encelto – Neurotech), an intravitreal allogeneic cell-based gene therapy, has been approved by the FDA for treatment of idiopathic macular telangiectasia type 2 in adults. It is the first treatment to be approved in the US for this indication.

The goal of drug therapy for type 2 diabetes is to achieve and maintain a near-normal glycated hemoglobin (A1C) concentration without inducing hypoglycemia; for most patients, the target A1C is <7%. Metformin is the preferred first-line treatment, but most patients with type 2 diabetes eventually require multidrug therapy and/or insulin to achieve glycemic control.

Pharmacologic management of chronic heart failure (HF) is primarily determined by the patient's left ventricular ejection fraction (LVEF) and severity of symptoms. Patients with chronic HF who have an LVEF ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF) and those with an LVEF ≥50% are considered to have heart failure with preserved ejection fraction (HFpEF). Patients with an LVEF of 41-49% have heart failure with mildly reduced or mid-range ejection fraction.

The FDA has approved the proton pump inhibitor (PPI) esomeprazole strontium for use in adults for the same indications as esomeprazole magnesium (Nexium): treatment of gastroesophageal reflux disease (GERD), prevention of NSAID-induced gastric ulcers, eradication of Helicobacter pylori, and treatment of pathological hypersecretory conditions. It was first marketed in December 2013 as a branded drug (Esomeprazole Strontium) and a month later as a generic drug.Strontium is incorporated into bone. It is not recommended for use in children or during pregnancy because of the absence of safety data...

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for treatment of children 2-17 years old who are hospitalized with COVID-19 and require oxygen support.

The possibility that use of mifepristone (Mifeprex, and generics) may be restricted has led to questions about alternatives for medication abortion.

Four new drugs have become available in the USA for HIV infection or its complications. Nevirapine (Viramune - Roxane), intravenous cidofovir (Vistide - Gilead), and amphotericin B oral suspension (Fungizone Oral Suspension - Bristol-Myers Squibb) have been approved by the US Food and Drug Administration; nelfinavir (Viracept - Agouron) is currently available only through an "Expanded Access Program."

Cefdinir (Omnicef - Parke-Davis), a third-generation oral cephalosporin, has been approved by the FDA for treatment of acute sinusitis, otitis media, acute exacerbations of chronic bronchitis, pharyngitis, community-acquired pneumonia and skin infections. Other drugs available for these indications are reviewed in The Medical Letter Handbook of Antimicrobial Therapy, 1998.