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Results For "U.S.-Food-and-Drug-Administration"

487 News Found

Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


US FDA approves Medtronic’s TAVR System
Drug Approval | August 25, 2021

US FDA approves Medtronic’s TAVR System

The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment


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


US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction
Drug Approval | August 20, 2021

US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction

New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US


FDA grants Emergency Use Authorization for next-generation Covid-19 assays
Digitisation | August 19, 2021

FDA grants Emergency Use Authorization for next-generation Covid-19 assays

Thermo Fisher’s kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes Covid-19


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


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


Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee
Drug Approval | August 12, 2021

Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee

The company is eligible for 12 months exclusivity from launch


ALS drug RADICAVA holds promise as it completes four years in US
News | August 10, 2021

ALS drug RADICAVA holds promise as it completes four years in US

Nearly 6,000 patients have been treated with the drug since 2017