Pharmaceutical Technology

SEPTEMBER 5, 2022

The US Food and Drug Administration (FDA) has approved the expanded usage of Vertex Pharmaceuticals ’ Orkambi (lumacaftor/ivacaftor) to treat cystic fibrosis (CF) in children aged 12 months to under 24 months. It enrolled 46 children aged one to under two years with the F/F genotype.

FDA Approval 130

FDA Approval Genotype Clinical Trials Clinical Trials 130

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. 0 genotypes. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0

Gene Therapy 246

Gene Therapy Gene Genotype In-Vivo 246

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

FDA Approval Production RNA Medicine 52

Delveinsight

DECEMBER 13, 2020

It was approved as a part of therapy for HCV GT1 and GT4 with PegINF-? Hepatitis C treatment options, without a doubt, have improved significantly, including pan-genotypic medications that are used to treat all genotypes and subtypes. Epclusa) was developed as the first drug therapy to treat all hepatitis C genotypes.

Genotype 52

Genotype FDA Approval DNA Drugs 52

XTalks

JULY 10, 2024

“This simple-to-use test detects the full range of known HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick,” said Dr. David H. Persing, Cepheid’s chief medical and scientific officer in Cepheid’s press release. billion in 2018 and is projected to reach $9.84

RNA 97

RNA In-Vitro Genotype Marketing 97

XTalks

MARCH 3, 2021

Today’s action marks the first FDA approval for a therapy to treat this devastating disease,” said Hylton V. Joffe, MD, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a press announcement from the FDA.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64