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Top 30 New Medical Devices of 2024

XTalks

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19.

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Ixchiq Wins FDA Approval as World’s First Chikungunya Vaccine

XTalks

The FDA says chikungunya is an emerging global health threat as at least 5 million cases of chikungunya virus infection have been reported in the last 15 years. Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

HDFN is a condition where the mother’s antibodies attack the red blood cells (RBCs) of the fetus or newborn, leading to hemolysis, or rapid destruction of the baby’s RBCs. Currently, there are no approved non-surgical treatments for pregnancies at high risk of this condition.

Trials 97
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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Basel, 17 August 2020.

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Using bispecific antibodies to advance cancer immunotherapy

pharmaphorum

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS

The Pharma Data

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S.

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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).