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Edwards gains expanded TAVR label for asymptomatic patients
The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.
Fierce Biotech2h
Element Science’s wearable defibrillator patch wins FDA approval
The Jewel wearable cardioverter defibrillator system can be worn during sleep and showers, with its low-profile and ...
The FDA Just Approved the First CRISPR-Edited Pigs for Food
PIC's gene-edited pigs are highly resistant to one of the most harmful viruses affecting pig populations worldwide today.
MyChesCo on MSN2d
FDA Approves Johnson & Johnson’s IMAAVY for Generalized Myasthenia Gravis
On Wednesday, the U.S. Food and Drug Administration (FDA) granted approval for IMAAVY™ (nipocalimab-aahu), Johnson & ...
US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss
The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...
Novo Nordisk says oral version of Wegovy accepted for FDA review
Novo Nordisk (NVO) stock in focus as oral Wegovy is accepted for FDA review for chronic weight management. Read more here.
Medical Device Network on MSN7d
Medtronic’s defibrillation lead gains FDA approval for use in right ventricle
The US Food and Drug Administration (FDA) has granted approval for Medtronic’s OmniaSecure defibrillation lead intended for ...
WCVB Channel 5 Boston24d
FDA says it will phase out animal testing requirement for monoclonal antibodies, drugs
To get FDA approval, scientists must be able to demonstrate that a new drug or treatment is safe and effective. And currently, before they can test a new therapy in humans, they must show proof ...