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Results For "U.S"

1563 News Found

Novavax submits variations to expand approval in Australia and New Zealand for adolescents
Biotech | May 08, 2022

Novavax submits variations to expand approval in Australia and New Zealand for adolescents

If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand


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


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


Eugia Pharma receives USFDA approval for Bortezomib
Drug Approval | May 04, 2022

Eugia Pharma receives USFDA approval for Bortezomib

The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA


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


India’s Drugs Controller General green lights trial of TRIA heart valve
News | May 04, 2022

India’s Drugs Controller General green lights trial of TRIA heart valve

The procedures have been performed by Dr. Kaushal Pandey at P.D. Hinduja Hospital in Mumbai, India


Gland launches Bortezomib in the US market
Drug Approval | May 04, 2022

Gland launches Bortezomib in the US market

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma


Physicians foresee an Alzheimer's Disease treatment revolution supported by advanced testing tools
Biotech | May 02, 2022

Physicians foresee an Alzheimer's Disease treatment revolution supported by advanced testing tools

Blood test for early detection of Alzheimer's Disease (AD) risk will lead to better patient care, physicians say; US. adults call for earlier evaluation and more education


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