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Results For "Food-and-Drug-Administration"

1015 News Found

Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma


Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir
News | October 11, 2021

Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir

If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19


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)


Gland Pharma receives tentative nod for Sugammadex injection
Drug Approval | October 09, 2021

Gland Pharma receives tentative nod for Sugammadex injection

The injection is used to reverse the effects of the muscle relaxants given to patients during surgery


Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
Biotech | October 09, 2021

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year


Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation
Biotech | October 09, 2021

Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022


PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel
Medical Device | October 07, 2021

PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel

RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus


Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India


AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA
Biotech | October 01, 2021

Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA

The company plans to submit the IND application by the end of 2021