Cloudbyz

JULY 31, 2024

The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics. This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

In-Vitro 69

In-Vitro Radiology Cosmetics Medicine 69

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.

RNA 97

RNA In-Vitro Genotype Marketing 97

The Pharma Data

MARCH 25, 2022

This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1,

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

The Pharma Data

MARCH 29, 2022

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, 4-6 New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

NOVEMBER 18, 2021

1 This includes people with blood cancers or other cancers being treated with chemotherapy, cases on dialysis, those taking specifics after an organ transplant or who are taking immunosuppressive medicines for conditions including multiple sclerosis and rheumatoidarthritis.2-6.

Trials 52

Trials Antibody In-Vitro Vaccine 52

The Pharma Data

JUNE 25, 2021

Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the trial, said: “The results of STORM CHASER suggest that AZD7442 may be useful in preventing symptomatic COVID-19 in individuals not already infected. AZD7442 was well tolerated in the trial.

Trials 52

Trials Antibody In-Vitro Medicine 52