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Resmetirom (Rezdiffra) for Metabolic Dysfunction-Associated Steatohepatitis
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
to advanced fibrosis. Its long-term efficacy and
safety are unknown.
Table 1. Pharmacology
Class Thyroid ...
Resmetirom (Rezdiffra – Madrigal), a thyroid hormone
receptor-beta agonist, has received accelerated
approval from the FDA for treatment of noncirrhotic
nonalcoholic steatohepatitis (NASH) with moderate
to advanced fibrosis in adults. NASH has recently
been renamed metabolic dysfunction-associated
steatohepatitis (MASH). Resmetirom is the first drug
to be approved in the US for this indication.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):65-6 doi:10.58347/tml.2024.1701a | Show Introduction Hide Introduction
A New Indication for Semaglutide (Wegovy)
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide (Wegovy) has been
approved by the FDA ...
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide (Wegovy) has been
approved by the FDA to reduce the risk of major
adverse cardiovascular events (MACE) in adults with
established cardiovascular disease (CVD) and either
obesity or overweight. Semaglutide is the first drug
to be approved for cardiovascular risk reduction in
this population. It is also approved in a lower-dose
injectable formulation as Ozempic and in an oral
formulation as Rybelsus (see Table 1).
Med Lett Drugs Ther. 2024 Apr 29;66(1701):66-7 doi:10.58347/tml.2024.1701b | Show Introduction Hide Introduction
Intravenous Acetaminophen/Ibuprofen (Combogesic IV)
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
ibuprofen
(Caldolor) and acetaminophen have been available in
the US for years.1,2
NONOPIOIDS FOR PAIN ...
The FDA has approved Combogesic IV (Hikma), an IV
solution containing acetaminophen and ibuprofen, to
treat mild to moderate pain (alone) or moderate to
severe pain (in combination with an opioid) in adults
when IV analgesia is considered clinically necessary.
Single-drug IV solutions containing ibuprofen
(Caldolor) and acetaminophen have been available in
the US for years.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):68-9 doi:10.58347/tml.2024.1701c | Show Introduction Hide Introduction
iDose TR — A Travoprost Implant for Glaucoma
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
; Durysta, an intracameral implant
containing the prostaglandin analog bimatoprost,
was the first.1 ...
The FDA has approved iDose TR (Glaukos), an
intracameral implant containing the prostaglandin
analog (PGA) travoprost, for reduction of intraocular
pressure (IOP) in patients with open-angle glaucoma
or ocular hypertension. Travoprost is also available
as a topical ophthalmic solution (Travatan Z, and
generics) for the same indication. iDose TR is the
second ocular implant to become available in the US
for this indication; Durysta, an intracameral implant
containing the prostaglandin analog bimatoprost,
was the first.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):70-1 doi:10.58347/tml.2024.1701d | Show Introduction Hide Introduction
Antibiotic Prophylaxis for Dental Procedures
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
Antibiotic Prophylaxis for Dental Procedures
Volume 66 (Issue 1701) April 29, 2024
Table 1 ...
Since 2007, antimicrobial prophylaxis for dental
procedures has been recommended to prevent
viridans group streptococcal infective endocarditis
only for patients at highest risk of an adverse
outcome. Limiting use to such patients does not
appear to have led to an increased incidence of
infective endocarditis or increased mortality due to
infective endocarditis.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):71-2 doi:10.58347/tml.2024.1701e | Show Introduction Hide Introduction
Tepotinib (Tepmetko) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
cancer cells.
Table 1. Pharmacology
Class Kinase inhibitor
Formulation 225 mg tablets
Route Oral ...
The FDA has granted regular approval to the oral
kinase inhibitor tepotinib (Tepmetko – EMD Serono)
for treatment of adults with metastatic non-small
cell lung cancer (NSCLC) harboring mesenchymal-epithelial
transition (MET) exon 14 skipping
alterations. MET exon 14 skipping mutations occur
in 3-4% of NSCLC cases and are associated with
advanced disease and a poor prognosis. Tepotinib
received accelerated approval for the same indication
in 2021 based on initial overall response rates and
duration of response.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):e73-4 doi:10.58347/tml.2024.1701f | Show Introduction Hide Introduction
Belzutifan (Welireg) for Advanced Renal Cell Carcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
cell carcinoma
(RCC) in adults who received prior treatment with a
programmed death receptor-1 (PD-1 ...
Belzutifan (Welireg – Merck), a first-in-class hypoxia-inducible
factor inhibitor, has been approved by the
FDA for treatment of advanced renal cell carcinoma
(RCC) in adults who received prior treatment with a
programmed death receptor-1 (PD-1) or programmed
death-ligand 1 (PD-L1) inhibitor and a vascular
endothelial growth factor tyrosine kinase inhibitor
(VEGF-TKI). Belzutifan was previously approved for
use in patients with von Hippel-Lindau disease.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):e75-6 doi:10.58347/tml.2024.1701g | Show Introduction Hide Introduction
Lifileucel (Amtagvi): A Cellular Therapy for Melanoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 29, 2024 (Issue 1701)
receptor-1 (PD-1) inhibitor, and if BRAF V600
mutation-positive, a BRAF inhibitor with or without ...
Lifileucel (Amtagvi – Iovance), a tumor-derived
autologous T-cell immunotherapy, has received
accelerated approval from the FDA for one-time
treatment of adults with unresectable or metastatic
melanoma previously treated with a programmed
death receptor-1 (PD-1) inhibitor, and if BRAF V600
mutation-positive, a BRAF inhibitor with or without
a mitogen-activated kinase (MEK) inhibitor. It is the
first cellular therapy to be approved for use in solid
tumors. Accelerated approval of lifileucel was based
on objective response rates.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):e77-8 doi:10.58347/tml.2024.1701h | Show Introduction Hide Introduction
Roflumilast Foam (Zoryve) for Seborrheic Dermatitis
The Medical Letter on Drugs and Therapeutics • Apr 15, 2024 (Issue 1700)
) for
treatment of chronic obstructive pulmonary disease.1,2
A 0.15% cream formulation for treatment of atopic ...
The FDA has approved a 0.3% foam formulation of
the phosphodiesterase-4 (PDE4) inhibitor roflumilast
(Zoryve – Arcutis) for topical treatment of seborrheic
dermatitis in patients ≥9 years old. Roflumilast is
the first PDE4 inhibitor to be approved in the US for
this indication. It is also available in a 0.3% cream
formulation (Zoryve) for treatment of plaque psoriasis
and in an oral formulation (Daliresp, and generics) for
treatment of chronic obstructive pulmonary disease.
A 0.15% cream formulation for treatment of atopic
dermatitis in patients ≥6 years old will be reviewed...
Med Lett Drugs Ther. 2024 Apr 15;66(1700):57-9 doi:10.58347/tml.2024.1700a | Show Introduction Hide Introduction
Cabtreo: A Three-Drug Gel for Acne
The Medical Letter on Drugs and Therapeutics • Apr 15, 2024 (Issue 1700)
) significantly more than its vehicle
alone (see Table 1).
In a phase 2, randomized, double-blind trial, 741 ...
The FDA has approved Cabtreo (Bausch Health), a gel
containing the retinoid adapalene, the oxidizing agent
benzoyl peroxide, and the antibiotic clindamycin, for
treatment of acne vulgaris in patients ≥12 years old.
Cabtreo is the first three-drug topical formulation to
become available in the US for treatment of acne.
Med Lett Drugs Ther. 2024 Apr 15;66(1700):59-60 doi:10.58347/tml.2024.1700b | Show Introduction Hide Introduction