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

461 News Found

Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab
Drug Approval | September 01, 2021

Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab

JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis


US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


Dr. Reddy's announce launch two drugs in the US market
News | August 31, 2021

Dr. Reddy's announce launch two drugs in the US market

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP are available in one strength of 5 mg/2.5 mg capsules in bottle count sizes of 100


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


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