Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 97

Results For "Food-and-Drug-Administration"

1014 News Found

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


Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


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


USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine
News | August 23, 2021

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease


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 breakthrough device designation to Impella ECP, the world’s smallest heart pump
Drug Approval | August 19, 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min


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