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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.
Med Lett Drugs Ther. 2020 Jul 27;62(1603):119-20 |  Show IntroductionHide Introduction

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.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):15-6 |  Show IntroductionHide Introduction

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...
Med Lett Drugs Ther. 2021 Jun 28;63(1627):e104-5 |  Show IntroductionHide Introduction

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...
Med Lett Drugs Ther. 2021 Nov 1;63(1636):171-2 |  Show IntroductionHide Introduction

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...
Med Lett Drugs Ther. 2021 Dec 27;63(1640):201-2 |  Show IntroductionHide Introduction

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.
Med Lett Drugs Ther. 2022 Jan 10;64(1641):7-8 |  Show IntroductionHide Introduction

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 IntroductionHide 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 IntroductionHide 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 IntroductionHide 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...
Med Lett Drugs Ther. 2011 Apr 4;53(1361):25 |  Show IntroductionHide Introduction