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In Brief: Expanded Heart Failure Indication for Dapagliflozin (Farxiga)

   
The Medical Letter on Drugs and Therapeutics • Jun 26, 2023  (Issue 1679)
failure with reduced ejection fraction (HFrEF).1 The indication has now been expanded to include ...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) was approved by the FDA in 2020 to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF). The indication has now been expanded to include a reduction in the risk of urgent HF visits and use in adults with any left ventricular ejection fraction (LVEF).
Med Lett Drugs Ther. 2023 Jun 26;65(1679):101-2   doi:10.58347/tml.2023.1679c |  Show IntroductionHide Introduction

Lodoco: Low-Dose Colchicine for Cardiovascular Event Prevention

   
The Medical Letter on Drugs and Therapeutics • Oct 02, 2023  (Issue 1686)
for cardiovascular disease.1 MECHANISM OF ACTION — Inflammation is thought to play an important role ...
Colchicine (Colcrys, and others), which has been available in the US for decades for prophylaxis and treatment of gout flares and other indications in oral formulations that contain 0.6 mg of the drug, has now been approved in 0.5-mg tablets as Lodoco (Agepha) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple risk factors for cardiovascular disease.
Med Lett Drugs Ther. 2023 Oct 2;65(1686):156-7   doi:10.58347/tml.2023.1686b |  Show IntroductionHide Introduction

In Brief: Extended-Release Budesonide (Ortikos) for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • Nov 02, 2020  (Issue 1610)
to be approved for this indication; Entocort EC, an ileal-release formulation, was the first.1 A third oral ...
An oral extended-release formulation of the corticosteroid budesonide (Ortikos – Ferring) is now available for once-daily treatment of mild to moderate active Crohn's disease of the ileum and/or ascending colon in patients ≥8 years old and for maintenance of remission for up to 3 months in adults. Ortikos is the second oral formulation of budesonide to be approved for this indication; Entocort EC, an ileal-release formulation, was the first. A third oral formulation of budesonide (Uceris) is approved for induction of remission in patients with mild to moderate active ulcerative...
Med Lett Drugs Ther. 2020 Nov 2;62(1610):176 |  Show IntroductionHide Introduction

Comparison Chart: Interleukin (IL) Receptor Antagonists for Atopic Dermatitis (online only)

   
The Medical Letter on Drugs and Therapeutics • Feb 17, 2025  (Issue 1722)
– Dupixent (Sanofi/Regeneron) 200 mg/1.14 mL, 300 mg/2 mL prefilled pens, syringes IL-4 and IL-13 inhibitor ...
View the Comparison Chart: Interleukin (IL) Receptor Antagonists for Atopic Dermatitis
Med Lett Drugs Ther. 2025 Feb 17;67(1722):e1   doi:10.58347/tml.2025.1722f |  Show IntroductionHide Introduction

Comparison Table: Inhaled Drugs for Treatment of COPD (online only)

   
The Medical Letter on Drugs and Therapeutics • Sep 02, 2024  (Issue 1710)
90 mcg/inh 90 mcg/inh 0.63, 1.25, 2.5 mg/3 mL soln HFA MDI (200 inh/unit) HFA MDI (60, 200 inh ...
View the Comparison Table: Inhaled Drugs for Treatment of COPD
Med Lett Drugs Ther. 2024 Sep 2;66(1710):e143-7   doi:10.58347/tml.2024.1710b |  Show IntroductionHide Introduction

Etrasimod (Velsipity) for Ulcerative Colitis

   
The Medical Letter on Drugs and Therapeutics • Nov 27, 2023  (Issue 1690)
Etrasimod (Velsipity) for Ulcerative Colitis The oral sphingosine 1-phosphate (S1P) receptor ...
The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.
Med Lett Drugs Ther. 2023 Nov 27;65(1690):187-9   doi:10.58347/tml.2023.1690b |  Show IntroductionHide Introduction

IV Ferric Carboxymaltose (Injectafer) for Iron Deficiency in Heart Failure

   
The Medical Letter on Drugs and Therapeutics • Feb 05, 2024  (Issue 1695)
with reduced quality of life and increased hospitalization and mortality.1 Injectafer is the first IV iron ...
Ferric carboxymaltose (Injectafer – American Regent) is now FDA-approved for IV treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure to improve exercise capacity. Iron deficiency is present in approximately 30% of patients with heart failure; it has been associated with reduced quality of life and increased hospitalization and mortality. Injectafer is the first IV iron preparation to be approved for this indication. It was previously approved for treatment of iron deficiency anemia in children and adults.
Med Lett Drugs Ther. 2024 Feb 5;66(1695):22-4   doi:10.58347/tml.2024.1695d |  Show IntroductionHide Introduction

Ganaxolone (Ztalmy) for CDKL5 Deficiency Disorder (online only)

   
The Medical Letter on Drugs and Therapeutics • Aug 19, 2024  (Issue 1709)
and a female to male ratio of 4:1. It is characterized by early onset (within 3 months of birth), multiple ...
The FDA has approved ganaxolone (Ztalmy – Marinus) for oral treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in patients ≥2 years old. It is the first drug to be approved in the US for this indication.
Med Lett Drugs Ther. 2024 Aug 19;66(1709):e139-40   doi:10.58347/tml.2024.1709g |  Show IntroductionHide Introduction

Iptacopan (Fabhalta) for Paroxysmal Nocturnal Hemoglobinuria (online only)

   
The Medical Letter on Drugs and Therapeutics • Sep 30, 2024  (Issue 1712)
(estimated prevalence 38 cases per 1,000,000 persons) caused by a severe deficiency in the complement ...
The FDA has approved the complement factor B inhibitor iptacopan (Fabhalta – Novartis) for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. Iptacopan is the first oral drug to be approved in the US for this indication. Three parenterally administered drugs, the complement C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris) and the complement C3 inhibitor pegcetacoplan (Empaveli), are also approved for treatment of PNH.
Med Lett Drugs Ther. 2024 Sep 30;66(1712):e171-3   doi:10.58347/tml.2024.1712e |  Show IntroductionHide Introduction

Guselkumab (Tremfya) — An IL-23 Antagonist for Crohn's Disease

   
The Medical Letter on Drugs and Therapeutics • Jun 09, 2025  (Issue 1730)
earlier for treatment of ulcerative colitis (UC), plaque psoriasis, and psoriatic arthritis.1 The IL-23 ...
The injectable interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults; it was approved earlier for treatment of ulcerative colitis (UC), plaque psoriasis, and psoriatic arthritis. The IL-23 antagonists risankizumab (Skyrizi) and mirikizumab (Omvoh) and the IL-12/23 antagonist ustekinumab (Stelara, and biosimilars) are also approved for treatment of CD.
Med Lett Drugs Ther. 2025 Jun 9;67(1730):92-4   doi:10.58347/tml.2025.1730c |  Show IntroductionHide Introduction