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77 News Found

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery
Drug Approval | November 30, 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications


Tezepelumab granted Orphan Drug Designation in the US
Biotech | October 09, 2021

Tezepelumab granted Orphan Drug Designation in the US

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


Japan approves AstraZeneca’s Forxiga for chronic kidney disease
Drug Approval | August 28, 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options


U.S. FDA approval of KORSUVA injection
News | August 24, 2021

U.S. FDA approval of KORSUVA injection

First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis


USFDA grants distinct indication for Chronic Sleep Disorder
Drug Approval | August 13, 2021

USFDA grants distinct indication for Chronic Sleep Disorder

Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder