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The Medical Letter on Drugs and Therapeutics • June 28, 2021 (Issue 1627)
The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same...
The Medical Letter on Drugs and Therapeutics • May 31, 2021 (Issue 1625)
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.
The Medical Letter on Drugs and Therapeutics • May 17, 2021 (Issue 1624)
On April 23, 2021, on advice from the Advisory Committee on Immunization Practices (ACIP), the FDA and CDC recommended that use of the Johnson...
The Medical Letter on Drugs and Therapeutics • May 3, 2021 (Issue 1623)
A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.
The Medical Letter on Drugs and Therapeutics • May 3, 2021 (Issue 1623)
The oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan (Entresto – Novartis) was approved in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF; LVEF <40%). The FDA has now expanded its...
The Medical Letter on Drugs and Therapeutics • May 3, 2021 (Issue 1623)
The CDC has issued new recommendations for treatment of gonococcal infection. A single 500-mg IM dose (1000 mg in patients weighing ≥150 kg) of the third-generation cephalosporin ceftriaxone is now the treatment of choice for patients with uncomplicated urogenital, rectal, or pharyngeal gonorrhea.
The Medical Letter on Drugs and Therapeutics • May 3, 2021 (Issue 1623)
On April 13, 2021, the FDA and CDC advised suspending use of the Johnson...
The Medical Letter on Drugs and Therapeutics • April 5, 2021 (Issue 1621)
The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for...
The Medical Letter on Drugs and Therapeutics • April 5, 2021 (Issue 1621)
The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults. Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent...
The Medical Letter on Drugs and Therapeutics • April 5, 2021 (Issue 1621)
View the COVID-19 Vaccine Comparison Chart
The Medical Letter on Drugs and Therapeutics • March 22, 2021 (Issue 1620)
On February 27, 2021, the FDA issued an Emergency Use Authorization (EUA) for the Johnson...
The Medical Letter on Drugs and Therapeutics • January 25, 2021 (Issue 1616)
On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.
The Medical Letter on Drugs and Therapeutics • January 11, 2021 (Issue 1615)
A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009....
The Medical Letter on Drugs and Therapeutics • January 11, 2021 (Issue 1615)
The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.
The Medical Letter on Drugs and Therapeutics • December 28, 2020 (Issue 1614)
The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV) to be administered together by IV infusion or SC injection for treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years old and weigh ≥40 kg) who are at high risk of progressing to severe COVID-19 and/or...
The Medical Letter on Drugs and Therapeutics • December 28, 2020 (Issue 1614)
The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of confirmed or suspected COVID-19 in hospitalized patients ≥2 years old who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); the EUA requires that baricitinib be used in combination with the IV...
The Medical Letter on Drugs and Therapeutics • December 3, 2020 (Issue )
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review two requests for Emergency Use Authorization (EUA) of COVID-19 vaccine candidates this month. They will review Pfizer and BioNTech's request on December 10 and Moderna's request on December 17. Both meetings will be webcast from the FDA's website and streamed on Facebook, Twitter, and YouTube.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now recommended in persons at increased risk for meningococcal disease (see Table 1). MenB booster doses were not recommended previously for any population.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
The investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).