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Results For "Food-and-Drug-Administration"

1018 News Found

U.S. FDA approves Bristol Myers Squibb’s Orencia
Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant


Pfizer’s Covid-19 drug 90 % effective
News | December 15, 2021

Pfizer’s Covid-19 drug 90 % effective

The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune


Lupin’s Goa plant receives EIR from US FDA
News | December 14, 2021

Lupin’s Goa plant receives EIR from US FDA

FDA changes inspection classification of the facility to Voluntary Action Indicated


Dr Reddy’s launch Venlafaxine ER tablets in the US
Drug Approval | December 10, 2021

Dr Reddy’s launch Venlafaxine ER tablets in the US

The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Gland Pharma receives tentative approval for Cangrelor
Drug Approval | December 09, 2021

Gland Pharma receives tentative approval for Cangrelor

Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity


USFDA authorises Astra’s antibody cocktail to prevent Covid
Drug Approval | December 09, 2021

USFDA authorises Astra’s antibody cocktail to prevent Covid

Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19


Dr Reddy’s launch valsartan tablets in the US market
Drug Approval | December 09, 2021

Dr Reddy’s launch valsartan tablets in the US market

Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90


Philips receives FDA 510(k) clearance for acute patient monitors
Digitisation | December 09, 2021

Philips receives FDA 510(k) clearance for acute patient monitors

Philips Patient Monitors IntelliVue MX750 and IntelliVue MX850 pair with advanced software and services to offer clinical decision support, continuous, scalable patient management and enhanced infection control