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Results For "U.S.-Food-and-Drug-Administration"

489 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


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


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


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


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


Juniper Biologics signs exclusive license agreement with Helsinn for infigratinib (INN) for the emerging markets including India
Biotech | May 04, 2022

Juniper Biologics signs exclusive license agreement with Helsinn for infigratinib (INN) for the emerging markets including India

Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication


Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis
Drug Approval | May 01, 2022

USFDA approves Rinvoq as an oral treatment for ankylosing spondylitis

The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases