Search Results for "data"
Search again or select article below to purchase. Single article price: $45. Order 3 or more at one time and receive a 10% discount.
Sort by relevance | Sort by date
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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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.
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.
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.