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Results For "FDA"

1710 News Found

India approves LumiraDX’s Antigen test kit
Medical Device | October 21, 2021

India approves LumiraDX’s Antigen test kit

The test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of Covid-19


Syngene revenue from operations up 17 per cent in Q2FY22
News | October 21, 2021

Syngene revenue from operations up 17 per cent in Q2FY22

The quarter also saw continued investment in new technologies and the successful implementation of several digitization and automation projects across operations


Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts
News | October 21, 2021

Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts

Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


Dr Reddy’s Lab launches carmustine in the US market
Drug Approval | October 16, 2021

Dr Reddy’s Lab launches carmustine in the US market

The BiCNU brand and generic market had U.S. sales of approximately US $ 19.4 million MAT for the most recent twelve months ending in August 2021, according to IQVIA Health


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


PCI Pharma Services acquires LSNE for its CDMO business
News | October 13, 2021

PCI Pharma Services acquires LSNE for its CDMO business

Transformational partnership establishes PCI as a CDMO and broadens capabilities across drug product lifecycle


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


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