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Results For "U.S"

1563 News Found

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis
Drug Approval | May 21, 2022

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date


AbbVie submits NDA for treatment of advanced Parkinson’s disease
Biotech | May 21, 2022

AbbVie submits NDA for treatment of advanced Parkinson’s disease

If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs


Glenmark receives sANDA approval for Abiraterone Acetate tablets
Drug Approval | May 20, 2022

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million


USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain
Supply Chain | May 20, 2022

USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain

Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages


Grand Opening of Kodiak Sciences’ bioconjugation facility
Biotech | May 19, 2022

Grand Opening of Kodiak Sciences’ bioconjugation facility

Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases


IAVI and Moderna launch first-in-Africa clinical trial of mRNA HIV vaccine
Biotech | May 19, 2022

IAVI and Moderna launch first-in-Africa clinical trial of mRNA HIV vaccine

Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity


CDSCO approves Jardiance for heart failure with preserved ejection fraction
Drug Approval | May 19, 2022

CDSCO approves Jardiance for heart failure with preserved ejection fraction

With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction


Agilent companion diagnostic expands CE-IVD Mark in Europe to include cervical cancer
Medical Device | May 18, 2022

Agilent companion diagnostic expands CE-IVD Mark in Europe to include cervical cancer

Globally, cervical cancer is the fourth most common cancer among women, with approximately 30,447 new cases diagnosed in Europe in 2020


University of Nebraska Medical Center and ANANDA Scientific announce USFDA approval
Biotech | May 17, 2022

University of Nebraska Medical Center and ANANDA Scientific announce USFDA approval

The study will evaluate the effectiveness of Nantheia ATL5, an investigational drug using cannabidiol in ANANDA’s proprietary delivery technology


Antengene announces commercial availability of Xpovio in China
Biotech | May 16, 2022

Antengene announces commercial availability of Xpovio in China

The drug will be available in 600 hospitals and 105 DTPs