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Searched for 1. Results 181 to 190 of 545 total matches.
Cemiplimab (Libtayo) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
in overall survival
were observed in patients with non-squamous and
squamous NSCLC.1
In one meta-analysis ...
The FDA has approved cemiplimab-rwlc (Libtayo –
Regeneron), an immune checkpoint inhibitor, for use in
combination with platinum-based chemotherapy for
first-line treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) in adults with no
epidermal growth factor receptor (EGFR), anaplastic
lymphoma kinase (ALK), or ROS1 aberrations and
who are not candidates for surgical resection or
chemoradiation. The drug was previously approved
for first-line treatment of NSCLC in patients whose
tumors have high PD-L1 expression and no genomic
tumor aberrations....
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e67-8 doi:10.58347/tml.2023.1674e | Show Introduction Hide Introduction
Pegcetacoplan (Syfovre) for Geographic Atrophy in Age-Related Macular Degeneration
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
and can eventually develop
severe vision loss.1 There has been no established
treatment for dry AMD ...
The FDA has approved the complement C3 inhibitor
pegcetacoplan (Syfovre – Apellis) for treatment of
geographic atrophy (GA) secondary to age-related
macular degeneration (AMD). Given as a series of
monthly or every-other-month (EOM) intravitreal
injections, it is the first drug to become available for
use in patients with atrophic dry AMD. Subcutaneous
pegcetacoplan was approved earlier as Empaveli for
treatment of paroxysmal nocturnal hemoglobinuria.
Med Lett Drugs Ther. 2023 Apr 3;65(1673):49-50 doi:10.58347/tml.2023.1673a | Show Introduction Hide Introduction
Avacincaptad Pegol (Izervay) for Geographic Atrophy in Age-Related Macular Degeneration
The Medical Letter on Drugs and Therapeutics • Jan 22, 2024 (Issue 1694)
), a complement C3 and C3b
inhibitor, was approved earlier.1
AGE-RELATED MACULAR DEGENERATION ― AMD
has two ...
The FDA has approved the complement C5 inhibitor
avacincaptad pegol (Izervay – Iveric) for intravitreal
treatment of geographic atrophy (GA) secondary
to age-related macular degeneration (AMD).
Avacincaptad pegol is the second complement
inhibitor to be approved in the US for this indication;
pegcetacoplan (Syfovre), a complement C3 and C3b
inhibitor, was approved earlier.
Med Lett Drugs Ther. 2024 Jan 22;66(1694):15-6 doi:10.58347/tml.2024.1694d | Show Introduction Hide Introduction
In Brief: A New Indication for Pemigatinib (Pemazyre) (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
myeloid/lymphoid neoplasms (MLNs) with fibroblast growth
factor receptor 1 (FGFR1) rearrangements ...
The oral kinase inhibitor pemigatinib (Pemazyre –
Incyte) has been approved by the FDA for treatment
of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth
factor receptor 1 (FGFR1) rearrangements. It is the
first targeted therapy to be approved in the US for this
indication. The drug received accelerated approval
from the FDA in 2020 for treatment of adults with
previously treated, unresectable, locally advanced or
metastatic cholangiocarcinoma with FGFR2 fusions
or other rearrangements.
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e71-2 doi:10.58347/tml.2023.1674g | Show Introduction Hide Introduction
PrabotulinumtoxinA (Jeuveau) for Frown Lines
The Medical Letter on Drugs and Therapeutics • May 20, 2019 (Issue 1572)
to be approved in the US for this indication
(see Table 1). It has been available in South Korea as
Nabota ...
The FDA has approved prabotulinumtoxinA-xvfs
(Jeuveau – Evolus) for temporary improvement in
the appearance of moderate to severe glabellar lines
associated with corrugator and/or procerus muscle
activity. Jeuveau is the fourth botulinum toxin
product to be approved in the US for this indication
(see Table 1). It has been available in South Korea as
Nabota since 2014.
Intranasal Diazepam (Valtoco) and Midazolam (Nayzilam) for Seizure Clusters
The Medical Letter on Drugs and Therapeutics • Apr 20, 2020 (Issue 1596)
time interval (6 to as long as 48
hours), with conscious recovery between seizures.1
Seizure clusters ...
The FDA has approved nasal spray formulations of
the benzodiazepines diazepam (Valtoco — Neurelis)
and midazolam (Nayzilam — UCB) for acute treatment
of intermittent episodes of frequent seizure activity
(seizure clusters). Diazepam rectal gel (Diastat, Diastat
AcuDial, and generics) has been used for this indication
for many years.
Baloxavir (Xofluza) for Post-Exposure Prophylaxis of Influenza
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021 (Issue 1615)
uncomplicated influenza in patients
≥12 years old in 2018.1 Two neuraminidase inhibitors
are FDA-approved ...
The oral polymerase acidic endonuclease inhibitor
baloxavir marboxil (Xofluza — Genentech) is now FDAapproved
for post-exposure prophylaxis of influenza
in patients ≥12 years old. Baloxavir was approved for
treatment of acute uncomplicated influenza in patients
≥12 years old in 2018.1 Two neuraminidase inhibitors
are FDA-approved for prophylaxis of influenza:
oseltamivir (Tamiflu, and generics) in patients ≥1 year
old, and zanamivir (Relenza) in patients ≥5 years old.2
Unlike oseltamivir and zanamivir, baloxavir is not FDA-approved
for pre-exposure prophylaxis of...
Varenicline Nasal Spray (Tyrvaya) for Dry Eye Disease
The Medical Letter on Drugs and Therapeutics • Dec 13, 2021 (Issue 1639)
was based on the results of two 28-
day, double-masked trials in patients with dry eye
disease (ONSET-1 ...
Tyrvaya (Oyster Point), a nasal spray formulation
of the cholinergic agonist varenicline, has been
approved by the FDA for treatment of dry eye disease.
It is the first nasal spray to be approved in the US
for this indication. An oral formulation of varenicline
(Chantix, and generics) has been available for years
for smoking cessation.
Sulbactam/Durlobactam (Xacduro) for Acinetobacter Pneumonia
The Medical Letter on Drugs and Therapeutics • Nov 27, 2023 (Issue 1690)
drugs, including carbapenems.1 Polymyxins B and E (colistin) have been used as salvage therapy ...
The FDA has approved Xacduro (Innoviva), a
combination of the beta-lactam antibacterial
sulbactam and the beta-lactamase inhibitor
durlobactam, for IV treatment of adults with hospital-acquired
or ventilator-associated bacterial pneumonia
caused by susceptible isolates of Acinetobacter
baumannii-calcoaceticus complex (ABC).
Med Lett Drugs Ther. 2023 Nov 27;65(1690):189-90 doi:10.58347/tml.2023.1690c | Show Introduction Hide Introduction
Solriamfetol (Sunosi) for Excessive Daytime Sleepiness
The Medical Letter on Drugs and Therapeutics • Aug 26, 2019 (Issue 1579)
, and insomnia.
▶ A schedule IV controlled substance.
▶ A 30-day supply costs $660.00.
Table 1. Pharmacology ...
The FDA has approved solriamfetol (Sunosi – Jazz),
a dopamine and norepinephrine reuptake inhibitor
(DNRI), to improve wakefulness in adults with excessive
daytime sleepiness (EDS) associated with narcolepsy
or obstructive sleep apnea (OSA). Pitolisant (Wakix),
an H3-receptor antagonist/inverse agonist recently
approved by the FDA for treatment of excessive
daytime sleepiness in patients with narcolepsy, will be
reviewed in a future issue.