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Searched for covid. Results 21 to 30 of 93 total matches.
An EUA for Bamlanivimab and Etesevimab for COVID-19
The Medical Letter on Drugs and Therapeutics • Apr 05, 2021 (Issue 1621)
An EUA for Bamlanivimab and Etesevimab for COVID-19 ...
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 use as monotherapy
in such patients in November 2020. Regeneron's
investigational monoclonal antibodies casirivimab
(REGN10933) and imdevimab (REGN10987) are also
authorized for use...
An EUA for Baricitinib (Olumiant) for COVID-19
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020 (Issue 1614)
An EUA for Baricitinib (Olumiant) for COVID-19 ...
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 antiviral drug remdesivir
(Veklury). Baricitinib has been available for treatment
of rheumatoid arthritis since 2018. Remdesivir was
recently approved by the FDA for treatment of COVID-19
in...
Antiviral Drugs for COVID-19 in Vaccinated Outpatients
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
Antiviral Drugs for COVID-19 in Vaccinated Outpatients ...
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and
oral molnupiravir (Lagevrio). Remdesivir is FDA-approved
for such use; nirmatrelvir/ritonavir and
molnupiravir are available under an FDA Emergency
Use Authorization. Because the pivotal clinical trials
of these products for outpatient use were conducted
in patients who were not vaccinated against
COVID-19, some clinicians have questioned whether
they can benefit vaccinated...
Med Lett Drugs Ther. 2023 Mar 6;65(1671):33-4 doi:10.58347/tml.2023.1671a | Show Introduction Hide Introduction
FDA Authorizes Johnson & Johnson COVID-19 Vaccine
The Medical Letter on Drugs and Therapeutics • Mar 22, 2021 (Issue 1620)
FDA Authorizes Johnson & Johnson COVID-19 Vaccine ...
On February 27, 2021, the FDA issued an Emergency
Use Authorization (EUA) for the Johnson & Johnson
adenovirus-based vaccine for prevention of COVID-19
in persons ≥18 years old. It is the third COVID-19
vaccine to become available in the US and the first to
require only a single dose. Two-dose mRNA-based
vaccines manufactured by Pfizer-BioNTech and
Moderna received EUAs in December 2020.
In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults
The Medical Letter on Drugs and Therapeutics • Dec 27, 2021 (Issue 1640)
In Brief: Booster Doses of mRNA-Based COVID-19 Vaccines for All Adults ...
On November 19, the FDA expanded the Emergency Use
Authorizations (EUAs) for the mRNA-based COVID-19
vaccines manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to include administration
of a booster dose for all adults ≥18 years old after
primary immunization with either the same COVID-19
vaccine or a different one. Booster doses of these
vaccines were previously authorized only for select
populations (age ≥65 years or persons at high risk for
severe COVID-19). The EUA for the adenovirus-based
vaccine manufactured by Johnson & Johnson was
amended in October 2021...
COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • Jan 09, 2023 (Issue 1667)
COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only) ...
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.
Med Lett Drugs Ther. 2023 Jan 9;65(1667):e9 doi:10.58347/tml.2023.1667d | Show Introduction Hide Introduction
COVID-19 Update: Baricitinib (Olumiant) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • Jun 13, 2022 (Issue 1652)
COVID-19 Update: Baricitinib (Olumiant) FDA-Approved for Treatment of COVID-19 (online only) ...
The FDA has approved the oral Janus kinase (JAK) inhibitor baricitinib (Olumiant) for treatment of COVID-19 in hospitalized adults who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for use in children 2-17 years old hospitalized with COVID-19 who require oxygen support.
Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19
The Medical Letter on Drugs and Therapeutics • Jan 10, 2022 (Issue 1641)
Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19 ...
The FDA has issued an Emergency Use Authorization
(EUA) for the investigational long-acting monoclonal
antibodies tixagevimab and cilgavimab (Evusheld –
AstraZeneca) to be administered concomitantly by IM
injection for pre-exposure prophylaxis of COVID-19 in
persons ≥12 years old who weigh ≥40 kg and have
either a history of severe allergy that prevents their
vaccination against COVID-19 or moderate or severe
immune compromise (see Table 1). They are the first
drugs to be authorized by the FDA for this indication.
Two other pairs of antibodies, bamlanivimab plus
etesevimab...
In Brief: Third Dose of mRNA-based COVID-19 Vaccines for Immunocompromised Persons
The Medical Letter on Drugs and Therapeutics • Sep 20, 2021 (Issue 1633)
In Brief: Third Dose of mRNA-based COVID-19 Vaccines for Immunocompromised Persons ...
The FDA has expanded the Emergency Use Authorizations
(EUAs) for the mRNA-based COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to include administration of a third
dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18
years old (Moderna) who have undergone solid organ
transplantation or have a condition that compromises
the immune system to a similar extent (see Table 1).
COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only)
The Medical Letter on Drugs and Therapeutics • Oct 31, 2022 (Issue 1662)
COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only) ...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include its use as a first booster dose in adults
who completed a primary series with any COVID-19
vaccine ≥6 months previously and are unable or
unwilling to receive a booster dose of a bivalent mRNA
vaccine. The Novavax vaccine is not authorized for
use in persons who have received a booster dose of
any other COVID-19 vaccine.