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Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis of COVID-19

   
The Medical Letter on Drugs and Therapeutics • Oct 18, 2021  (Issue 1635)
obstructive pulmonary disease 1. Adult and pediatric patients (≥12 years old and weighing ≥40 kg) with ≥1 ...
In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have...
Med Lett Drugs Ther. 2021 Oct 18;63(1635):163-4 |  Show IntroductionHide Introduction

Penbraya: A Pentavalent Meningococcal Vaccine

   
The Medical Letter on Drugs and Therapeutics • Mar 18, 2024  (Issue 1698)
, and Y (MenACWY; Menveo, MenQuadfi)1 and two meningococcal serogroup B vaccines (MenB; Bexsero ...
The FDA has licensed Penbraya (Pfizer), a pentavalent polysaccharide conjugate meningococcal vaccine, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penbraya is the only meningococcal vaccine that contains all five of these serogroups. Two quadrivalent polysaccharide conjugate meningococcal vaccines containing serogroups A, C, W, and Y (MenACWY; Menveo, MenQuadfi) and two meningococcal serogroup B vaccines (MenB; Bexsero, Trumenba) are available in the US (see Table...
Med Lett Drugs Ther. 2024 Mar 18;66(1698):43-5   doi:10.58347/tml.2024.1698b |  Show IntroductionHide Introduction

MenQuadfi - A New Meningococcal (A, C, W, and Y) Vaccine

   
The Medical Letter on Drugs and Therapeutics • May 17, 2021  (Issue 1624)
impairment. Rates of meningococcal disease are highest in infants ...
The FDA has licensed MenQuadfi (Sanofi Pasteur), a quadrivalent polysaccharide conjugate vaccine that uses tetanus toxoid as a protein carrier, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y (MenACWY) in persons ≥2 years old.
Med Lett Drugs Ther. 2021 May 17;63(1624):78-80 |  Show IntroductionHide Introduction

FDA Authorizes Moderna COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
on December 11, 2020.1 CLINICAL STUDY — Issuance of the EUA was based primarily on the results ...
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.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):9-10 |  Show IntroductionHide Introduction

In Brief: Oritavancin (Kimyrsa) for Skin and Skin Structure Infections (online only)

   
The Medical Letter on Drugs and Therapeutics • Aug 23, 2021  (Issue 1631)
for the same indication.1 Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time ...
The FDA has approved Kimyrsa (Melinta), a new IV formulation of the long-acting lipoglycopeptide antibiotic oritavancin, for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Orbactiv (Melinta), another IV formulation of oritavancin, was approved in 2014 for the same indication. Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time (1 hour vs 3 hours) compared to Orbactiv (see Table 1).
Med Lett Drugs Ther. 2021 Aug 23;63(1631):e1-2 |  Show IntroductionHide Introduction

Vaccination Recommendations for Updated 2024-2025 COVID-19 Vaccines (online only)

   
The Medical Letter on Drugs and Therapeutics • Mar 03, 2025  (Issue 1723)
: Three doses: 1st at week 0, 2nd at week 3-8, and 3rd ≥8 weeks after dose 25 1 previous Pfizer dose: One ...
View the Vaccination Recommendations for Updated 2024-2025 COVID-19 Vaccines
Med Lett Drugs Ther. 2025 Mar 3;67(1723):e1   doi:10.58347/tml.2025.1723g |  Show IntroductionHide Introduction

Drugs for Acne

   
The Medical Letter on Drugs and Therapeutics • Feb 05, 2024  (Issue 1695)
in 2016.1 PATHOGENESIS The pathogenesis of acne is multifactorial: follicular hyperkeratinization ...
Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.
Med Lett Drugs Ther. 2024 Feb 5;66(1695):17-20   doi:10.58347/tml.2024.1695a |  Show IntroductionHide Introduction

Molnupiravir - An Oral Antiviral Drug for COVID-19

   
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022  (Issue 1642)
of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative ...
The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...
Med Lett Drugs Ther. 2022 Jan 24;64(1642):10-1 |  Show IntroductionHide Introduction

Erdafitinib (Balversa) for Urothelial Carcinoma (online only)

   
The Medical Letter on Drugs and Therapeutics • May 13, 2024  (Issue 1702)
. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death ...
Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations who had disease progression on or after at least one prior line of systemic therapy. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death receptor-1) or PD-L1 (programmed death-ligand 1) inhibitor therapy. Erdafitinib is the first oral FGFR kinase inhibitor to be...
Med Lett Drugs Ther. 2024 May 13;66(1702):e83-4   doi:10.58347/tml.2024.1702g |  Show IntroductionHide Introduction

In Brief: Retifanlimab (Zynyz) for Merkel Cell Carcinoma (online only)

   
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023  (Issue 1674)
), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA ...
Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults. Accelerated approval of the drug was based on the response rate and duration of response. Retifanlimab is the third drug to be approved in the US for treatment of MCC; pembrolizumab (Keytruda), a PD-1 blocking antibody, is approved for the same indication as retifanlimab in patients ≥12 years old and avelumab (Bavencio), a programmed death...
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e73-4   doi:10.58347/tml.2023.1674h |  Show IntroductionHide Introduction