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Results For "USFDA"

1135 News Found

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


Sun gets 10 observations from USFDA for Halol facility
News | May 10, 2022

Sun gets 10 observations from USFDA for Halol facility

The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days


USFDA clears Abbott’s test to detect four sexually transmitted infections simultaneously
Drug Approval | May 06, 2022

USFDA clears Abbott’s test to detect four sexually transmitted infections simultaneously

Abbott's multiplex test runs on its most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes – detecting four infections simultaneously