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An EUA for Casirivimab and Imdevimab for COVID-19
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020 (Issue 1614)
1. High-Risk Conditions for COVID-19 Outpatients1
▶ Age ≥65 years
▶ BMI ≥25 kg/m2 (or, in patients ...
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 hospitalization.
An EUA for Baricitinib (Olumiant) for COVID-19
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020 (Issue 1614)
in combination with the IV antiviral drug remdesivir
(Veklury).1 Baricitinib has been available for treatment ...
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...
Pemigatinib (Pemazyre) for Cholangiocarcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020 (Issue 1614)
is given once daily in 21-day treatment cycles (2 weeks
on, 1 week off); one 21-day treatment cycle ...
The oral kinase inhibitor pemigatinib (Pemazyre –
Incyte) has received accelerated approval from
the FDA for treatment of adults with previously
treated, unresectable, locally advanced or metastatic
cholangiocarcinoma with fibroblast growth factor
receptor 2 (FGFR2) fusions or other rearrangements.
Pemigatinib is the first drug to be approved in the US
for this indication.
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: New Meningococcal Serogroup B Vaccination Recommendations
The Medical Letter on Drugs and Therapeutics • Nov 30, 2020 (Issue 1612)
on Immunization Practices
(ACIP) has issued new recommendations for meningococcal
vaccination.1 Booster ...
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.
An EUA for Bamlanivimab - A Monoclonal Antibody for COVID-19
The Medical Letter on Drugs and Therapeutics • Nov 30, 2020 (Issue 1612)
to severe disease and/or hospitalization (see Table 1).1 Monoclonal antibodies, such as bamlanivimab ...
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).
In Brief: Hydrochlorothiazide and Skin Cancer
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
carcinoma [SCC]) to the labels of products containing
the diuretic hydrochlorothiazide.1
The labeling ...
The FDA has required the addition of information about
an increased risk of nonmelanoma skin cancer (basal
cell carcinoma [BCC] and squamous cell carcinoma
[SCC]) to the labels of products containing the diuretic
hydrochlorothiazide.
Empagliflozin (Jardiance) for Heart Failure
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
diabetes.1 To date, empagliflozin has not been
approved by the FDA for such use. The SGLT2 inhibitor ...
In a randomized, placebo-controlled trial, the
sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly)
reduced the composite risk of cardiovascular death
or hospitalization for worsening heart failure (HF)
in patients with heart failure with reduced ejection
fraction (HFrEF), whether or not they had type 2
diabetes. To date, empagliflozin has not been
approved by the FDA for such use. The SGLT2 inhibitor
dapagliflozin (Farxiga) was approved by the FDA for
this indication earlier this year.
Orphengesic Forte - An Old Analgesic Combination Returns
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
and may be as effective as an opioid/acetaminophen combination for treatment of moderate to severe acute pain.1 MECHANISM ...
A fixed-dose combination of orphenadrine citrate, aspirin,
and caffeine (Orphengesic Forte – Galt; previously
available as Norgesic Forte) has been approved as
a prescription drug by the FDA for treatment of mild
to moderate pain caused by acute musculoskeletal
disorders. Single-ingredient generic orphenadrine
citrate is available by prescription in oral and injectable
formulations and has been used for years as an adjunct
for treatment of acute musculoskeletal pain. Orphengesic
Forte is being marketed as a non-opioid alternative for
pain relief.
Comparison Chart: SGLT2 Inhibitors (online only)
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
2 (SGLT2) INHIBITORS RENAL DOSAGE ADJUSTMENTS CANAGLIFLOZIN eGFR 30 to ...
View the Comparison Chart: SGLT2 Inhibitors