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Results For "USFDA"

1404 News Found

Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities
News | May 22, 2022

Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities

A total of five observations for Goa and 17 for Monroe


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


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


RadNet’s AI subsidiaries obtain USFDA clearance for mammography and prostrate AI tools
Drug Approval | May 17, 2022

RadNet’s AI subsidiaries obtain USFDA clearance for mammography and prostrate AI tools

Quantib Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist's reading station


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


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


USFDA approves Lilly and Incyte's Olumiant to treat hospitalised patients with Covid-19
Drug Approval | May 12, 2022

USFDA approves Lilly and Incyte's Olumiant to treat hospitalised patients with Covid-19

Olumiant is the first and only JAK inhibitor USFDA-approved for the treatment of Covid-19


Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII
News | May 11, 2022

Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII

The unit is an oral manufacturing facility at Jedcherla, Hyderabad


Alembic Pharmaceuticals receives USFDA  approval for Arformoterol Tartrate
Drug Approval | May 11, 2022

Alembic Pharmaceuticals receives USFDA approval for Arformoterol Tartrate

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies