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Searched for data. Results 171 to 180 of 369 total matches.

Hemgenix - A Gene Therapy for Hemophilia B

   
The Medical Letter on Drugs and Therapeutics • Jan 23, 2023  (Issue 1668)
prophylaxis therapy. Longer-term efficacy and safety data are needed. Letter hemophilia Hemgenix ...
Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive factor IX prophylaxis therapy or have had life-threatening or repeated, serious, spontaneous bleeding episodes. It is the first gene therapy to be approved in the US for this indication.
Med Lett Drugs Ther. 2023 Jan 23;65(1668):9-10   doi:10.58347/tml.2023.1668a |  Show IntroductionHide Introduction

Shockwave Therapy for Erectile Dysfunction

   
The Medical Letter on Drugs and Therapeutics • Nov 27, 2023  (Issue 1690)
from or cannot use an oral PDE5 inhibitor, but longer-term data are lacking. November 27, 2023 2. I Gruenwald ...
Low-intensity extracorporeal shockwave therapy similar to that used to fragment kidney stones or gallstones is a new option for treatment of erectile dysfunction that is now being advertised extensively in the US. It has not been approved by the FDA for treatment of erectile dysfunction.
Med Lett Drugs Ther. 2023 Nov 27;65(1690):190-1   doi:10.58347/tml.2023.1690d |  Show IntroductionHide Introduction

In Brief: A New OTC Naloxone Nasal Spray (RiVive)

   
The Medical Letter on Drugs and Therapeutics • Mar 18, 2024  (Issue 1698)
required for approval of RiVive. Approval was based on pharmacokinetic data (summarized in the FDA review ...
The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.
Med Lett Drugs Ther. 2024 Mar 18;66(1698):47-8   doi:10.58347/tml.2024.1698d |  Show IntroductionHide Introduction

Beqvez — Another Gene Therapy for Hemophilia B

   
The Medical Letter on Drugs and Therapeutics • Jun 10, 2024  (Issue 1704)
related to treating bleeding episodes. Longer-term efficacy data are needed.for at least 3 hours after ...
Fidanacogene elaparvovec-dzkt (Beqvez – Pfizer), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for treatment of adults with moderate to severe hemophilia B who do not have neutralizing antibodies to AAV serotype Rh74var and currently receive factor IX prophylaxis therapy or have had life-threatening hemorrhage or repeated, serious, spontaneous bleeding episodes. Beqvez is the second single-dose gene therapy to be approved in the US for treatment of hemophilia B; Hemgenix was the first.
Med Lett Drugs Ther. 2024 Jun 10;66(1704):95-6   doi:10.58347/tml.2024.1704d |  Show IntroductionHide Introduction

Eroxon — An OTC Gel for Erectile Dysfunction

   
The Medical Letter on Drugs and Therapeutics • Nov 11, 2024  (Issue 1715)
2024; 211:e1074. 5. Futura Medical. Eroxon clinical trial data. Available at: https:// bit.ly/3zgFsOv ...
The FDA has authorized over-the-counter (OTC) sale of a nonmedicated alcohol-based gel (Eroxon – Futura) for treatment of erectile dysfunction (ED) in males ≥22 years old. Eroxon is the only FDA-approved OTC and topical treatment for erectile dysfunction. It is also available in the UK and the EU.
Med Lett Drugs Ther. 2024 Nov 11;66(1715):181-2   doi:10.58347/tml.2024.1715c |  Show IntroductionHide Introduction

Zenocutuzumab (Bizengri) for NSCLC and Pancreatic Adenocarcinoma

   
The Medical Letter on Drugs and Therapeutics • Jan 20, 2025  (Issue 1720)
during treatment with zenocutuzumab and for 2 months after the last dose. No data are available ...
Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion in adults who had disease progression on or after prior systemic therapy. It is the first drug to be approved in the US for treatment of NRG1-positive cancers. Accelerated approval of zenocutuzumab was based on the overall response rate and duration of response.
Med Lett Drugs Ther. 2025 Jan 20;67(1720):15-6   doi:10.58347/tml.2025.1720e |  Show IntroductionHide Introduction

Comparison Chart: Some Drugs for Abdominal Pain in Irritable Bowel Syndrome (IBS) (online only)

   
The Medical Letter on Drugs and Therapeutics • Feb 03, 2025  (Issue 1721)
▪ May improve IBS symptoms, but high-quality data are lacking ▪ Often used prn for acute abdominal pain ...
View the Comparison Chart: Some Drugs for Abdominal Pain in Irritable Bowel Syndrome (IBS)
Med Lett Drugs Ther. 2025 Feb 3;67(1721):e1-2   doi:10.58347/tml.2025.1721d |  Show IntroductionHide Introduction

Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease

   
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021  (Issue 1615)
at the recommended dose. There are no data on the presence of opicapone in human breast milk or on its effects ...
The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):3-5 |  Show IntroductionHide Introduction

A Three-Antigen Hepatitis B Vaccine (PreHevbrio)

   
The Medical Letter on Drugs and Therapeutics • May 16, 2022  (Issue 1650)
%, respectively). PREGNANCY AND LACTATION — There are no data on the use of PreHevbrio in pregnant women ...
The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It has been available in Israel since 2000.
Med Lett Drugs Ther. 2022 May 16;64(1650):73-5 |  Show IntroductionHide Introduction

COVID-19 Update: Pfizer/BioNTech and Moderna Vaccines Authorized for Children ≥6 Months Old

   
The Medical Letter on Drugs and Therapeutics • Jul 11, 2022  (Issue 1654)
was based primarily on immunogenicity data; data on the efficacy of the vaccines in preventing infection ...
The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.
Med Lett Drugs Ther. 2022 Jul 11;64(1654):110-2 |  Show IntroductionHide Introduction