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Results For "Food-and-Drug-Administration"

1074 News Found

Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine
Biotech | May 13, 2022

Neurocrine Biosciences receives Orphan Drug Designation for Valbenazine

The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation


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


Ascletis announces U.S. IND approval of ASC22 for HIV patients
Biotech | May 11, 2022

Ascletis announces U.S. IND approval of ASC22 for HIV patients

ASC22 (Envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection


Bora Pharmaceuticals acquires Eden Biologics CDMO assets
Biotech | May 10, 2022

Bora Pharmaceuticals acquires Eden Biologics CDMO assets

Bora establishes a leadership position in Taiwan's CDMO sector as it continues to expand into the global CDMO market


InxMed raises US $ 15 million in Series B+ financing
Startup | May 09, 2022

InxMed raises US $ 15 million in Series B+ financing

The plan is to advance innovative therapies to drug-resistant cancers


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