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Results For "Food-and-Drug-Administration"

1074 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


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


Propanc Biopharma undertaking PRP manufacturing & development for human use
Biotech | May 20, 2022

Propanc Biopharma undertaking PRP manufacturing & development for human use

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection


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


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series


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


Inmagene receives USFDA IND clearance for a third-generation BTK inhibitor
Biotech | May 16, 2022

Inmagene receives USFDA IND clearance for a third-generation BTK inhibitor

It is developing the drug candidate to potentially treat immunological diseases


USFDA approves novel, dual-targeted treatment for type 2 diabetes
Drug Approval | May 15, 2022

USFDA approves novel, dual-targeted treatment for type 2 diabetes

In clinical trials, treatment proved more effective than other therapies evaluated