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Results For "USFDA"

1312 News Found

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


USFDA limits use of J&J Covid-19 vaccine to certain individuals
News | May 06, 2022

USFDA limits use of J&J Covid-19 vaccine to certain individuals

The FDA has determined that the known and potential benefits of the vaccine for the prevention of Covid-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible


Lupin receives USFDA approval for Pregabalin and Iloperidone
Drug Approval | May 06, 2022

Lupin receives USFDA approval for Pregabalin and Iloperidone

While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility


Zydus receives tentative approval from USFDA for Selexipag tablets
Drug Approval | May 06, 2022

Zydus receives tentative approval from USFDA for Selexipag tablets

The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad


USFDA permits marketing for new test to improve diagnosis of Alzheimer's disease
News | May 05, 2022

USFDA permits marketing for new test to improve diagnosis of Alzheimer's disease

According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer's disease, a brain disorder known to slowly destroy memory and thinking skills