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Golodirsen (Vyondys 53) for Duchenne Muscular Dystrophy
The Medical Letter on Drugs and Therapeutics • Jul 27, 2020 (Issue 1603)
corticosteroid
deflazacort (Emflaza) were approved earlier.1,2
THE DISORDER — DMD is a progressive, X-linked ...
Golodirsen (Vyondys 53 — Sarepta), an antisense
oligonucleotide, has received accelerated approval
from the FDA for treatment of Duchenne muscular
dystrophy (DMD) in the ~8% of patients who have
mutations of the dystrophin gene that are amenable
to exon 53 skipping. It is the first drug to be approved
for this indication and the third to be approved for
treatment of DMD; the antisense oligonucleotide
eteplirsen (Exondys 51) and the oral corticosteroid
deflazacort (Emflaza) were approved earlier.
Encorafenib (Braftovi) for Metastatic Colorectal Cancer
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021 (Issue 1616)
,
and oxaliplatin).1 After failure of initial therapy,
subsequent lines of therapy have minimal efficacy ...
The FDA has approved the oral kinase inhibitor
encorafenib (Braftovi – Pfizer), in combination with
the epidermal growth factor receptor (EGFR) inhibitor
cetuximab (Erbitux), for treatment of adults with
metastatic colorectal cancer (CRC) with a BRAF
V600E mutation. Encorafenib was approved in 2018
for use with the mitogen-activated kinase (MEK)
inhibitor binimetinib (Mektovi) for treatment of
unresectable or metastatic melanoma with a BRAF
V600E or V600K mutation.
Casimersen (Amondys 45) for Duchenne Muscular Dystrophy (online only)
The Medical Letter on Drugs and Therapeutics • Jun 28, 2021 (Issue 1627)
(Emflaza) were approved earlier.1-4 The
DMD gene consists of 79 exons; its long length makes ...
Casimersen (Amondys 45 – Sarepta), an IV antisense
oligonucleotide, has received accelerated approval
from the FDA for treatment of Duchenne muscular
dystrophy (DMD) in patients who have mutations
of the dystrophin gene that are amenable to exon
45 skipping (DMD-45), which occur in ~8% of DMD
cases. Casimersen is the first drug to be approved
for this indication and the fifth to be approved for
treatment of DMD; the IV antisense oligonucleotides
eteplirsen (Exondys 51), golodirsen (Vyondys 53),
and viltolarsen (Viltepso) and the oral corticosteroid
deflazacort (Emflaza) were...
Empagliflozin (Jardiance) for Heart Failure with Reduced Ejection Fraction
The Medical Letter on Drugs and Therapeutics • Nov 01, 2021 (Issue 1636)
in
2020.1 Empagliflozin has been granted breakthrough
therapy designation for treatment of patients ...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim)
has been approved by the FDA for a third indication: to
reduce the risk of hospitalization for heart failure (HF)
and cardiovascular death in patients with heart failure
with reduced ejection fraction (HFrEF), with or without
type 2 diabetes. The SGLT2 inhibitor dapagliflozin
(Farxiga) was approved for the same indication in
2020. Empagliflozin has been granted breakthrough
therapy designation for treatment of patients with
heart failure with preserved ejection fraction...
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)
one.1 Booster doses of these
vaccines were previously authorized only for select
populations (age ...
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...
In Brief: Twice-Yearly Paliperidone (Invega Hafyera) for Schizophrenia
The Medical Letter on Drugs and Therapeutics • Jan 10, 2022 (Issue 1641)
with a history of relapse due to poor
adherence to oral maintenance therapy. They are
Table 1. Long-Acting ...
Invega Hafyera (Janssen), a long-acting, extended-release
(ER) formulation of the second-generation
antipsychotic paliperidone palmitate, has been
approved by the FDA for twice-yearly IM treatment
of schizophrenia in adults who have been adequately
treated with another injectable ER formulation of the
drug (Invega Sustenna or Invega Trinza). It is the first
drug to become available in the US for twice-yearly
treatment of schizophrenia.
Futibatinib (Lytgobi) for Cholangiocarcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
; pemigatinib (Pemazyre)
was approved earlier.1
rearrangements, including fusions. Patients received ...
The oral kinase inhibitor futibatinib (Lytgobi –
Taiho) has received accelerated approval from the
FDA for treatment of adults with previously treated,
unresectable, locally advanced or metastatic
intrahepatic cholangiocarcinoma with fibroblast
growth factor receptor 2 (FGFR2) fusions or other
rearrangements. Accelerated approval was based
on the overall response rate and duration of
response. Futibatinib is the second drug to be
approved for this indication; pemigatinib (Pemazyre)
was approved earlier.
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e69-70 doi:10.58347/tml.2023.1674f | Show Introduction Hide Introduction
COVID-19 Update: An EUA for Vilobelimab (Gohibic) for COVID-19
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
is the first anti-C5a antibody to become
available in the US.1
STANDARD TREATMENT ― The NIH recommends ...
The investigational anti-complement component 5a
(C5a) antibody vilobelimab (Gohibic – InflaRx) has
been granted an FDA Emergency Use Authorization
(EUA) for IV treatment of hospitalized adults
with COVID-19 beginning within 48 hours after
invasive mechanical ventilation (IMV) or extracorporeal
membrane oxygenation (ECMO) is started.
Vilobelimab is the first anti-C5a antibody to become
available in the US.
Med Lett Drugs Ther. 2023 May 29;65(1677):86-7 doi:10.58347/tml.2023.1677d | Show Introduction Hide Introduction
Drugs for Postmenopausal Osteoporosis
The Medical Letter on Drugs and Therapeutics • Jul 08, 2024 (Issue 1706)
between -1.0 and
-2.5 with a history of fragility (low-trauma) fracture
of the hip or spine, or T-scores ...
Pharmacologic treatment is recommended for
postmenopausal women who have bone density
T-scores (standard deviations from normal mean
values in the spine, femoral neck, total hip, or distal
radius) of -2.5 or below, T-scores between -1.0 and
-2.5 with a history of fragility (low-trauma) fracture
of the hip or spine, or T-scores between -1.0 and
-2.5 with a FRAX 10-year probability of ≥3% for hip
fracture or ≥20% for major osteoporotic fracture.
Med Lett Drugs Ther. 2024 Jul 8;66(1706):105-12 doi:10.58347/tml.2024.1706a | Show Introduction Hide Introduction
In Brief: PPIs and Hypomagnesemia
The Medical Letter on Drugs and Therapeutics • Apr 04, 2011 (Issue 1361)
) can lead to hypomagnesemia.1
Normal serum concentrations of magnesium are 0.7-
1.0 mmol/L. About 30 ...
The FDA has warned that prolonged use of a proton pump inhibitor (PPI) can lead to hypomagnesemia.1 Normal serum concentrations of magnesium are 0.7-1.0 mmol/L. About 30 cases of severe hypomagnesemia (<0.5 mmol/L) have been reported in long-term PPI users; when the PPI was stopped, serum magnesium levels returned to normal in less than 2 weeks.2-5 The exact mechanism is unknown, but in some patients PPIs apparently interfere with active transport of magnesium across the intestinal wall or cause excessive loss into the intestinal lumen.6 Hypomagnesemia is often accompanied by hypocalcemia...