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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.
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.
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).
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 Introduction Hide 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...
Daridorexant (Quviviq) for Insomnia
The Medical Letter on Drugs and Therapeutics • Jul 11, 2022 (Issue 1654)
) and lemborexant (Dayvigo)
were approved earlier.1,2
Pronunciation Key
Daridorexant: da ree” doe rek’ sant ...
The FDA has approved daridorexant (Quviviq –
Idorsia), an orexin receptor antagonist, for treatment
of sleep-onset and/or sleep-maintenance insomnia
in adults. Daridorexant is the third orexin receptor
antagonist to be approved for this indication;
suvorexant (Belsomra) and lemborexant (Dayvigo)
were approved earlier.
Lonapegsomatropin (Skytrofa) for Growth Hormone Deficiency
The Medical Letter on Drugs and Therapeutics • Feb 07, 2022 (Issue 1643)
from their biosimilars.
Table 1. Pharmacology
Class Recombinant human growth hormone
Formulation 3, 3.6, 4.3, 5.2, 6.3 ...
Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for
once-weekly subcutaneous (SC) treatment of growth
failure due to inadequate secretion of endogenous
growth hormone in children ≥1 year old who weigh
≥11.5 kg. It is the first once-weekly rhGH product to be
approved in the US; other available rhGH formulations
are administered more frequently.
Teclistamab-cqyv (Tecvayli) For Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • Nov 14, 2022 (Issue 1663)
: The dose is titrated over one week, followed by 1.5
mg/kg SC once weekly.
▶ Cost: One dose for a 70-kg ...
Teclistamab-cqyv (Tecvayli – Janssen), a bispecific
B-cell maturation antigen (BCMA)-directed CD3
T-cell engager, has been granted accelerated
approval by the FDA for treatment of relapsed or
refractory multiple myeloma in adults who received
≥4 prior lines of therapy, including a proteasome
inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval
was based on response rate. Teclistamab is the first
bispecific BCMA-directed CD3 T-cell engager to be
approved in the US.
Remdesivir (Veklury) for COVID-19
The Medical Letter on Drugs and Therapeutics • Nov 30, 2020 (Issue 1612)
Remdesivir (Veklury) for COVID-19
Table 1. Pharmacology Class Antiviral drug Formulations 100 mg ...
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.
In Brief: A New Endometrial Cancer Indication for Dostarlimab (Jemperli) (online only)
The Medical Letter on Drugs and Therapeutics • Aug 21, 2023 (Issue 1683)
for curative
surgery or radiation.1
MECHANISM OF ACTION — Binding of PD-L1 and
PD-L2 to programmed death ...
The immune checkpoint inhibitor dostarlimab-gxly
(Jemperli – GSK) has been approved by the FDA for
use in combination with carboplatin and paclitaxel
for treatment of adults with mismatch repair deficient
(dMMR) or microsatellite instability-high (MSI-H)
primary advanced or recurrent endometrial cancer.
Dostarlimab was recently granted regular approval
for treatment of adults with dMMR recurrent or
advanced endometrial cancer that progressed on
or following a prior platinum-containing regimen in
any setting and who are not candidates for curative
surgery or radiation.
Med Lett Drugs Ther. 2023 Aug 21;65(1683):e138 doi:10.58347/tml.2023.1683f | Show Introduction Hide Introduction