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

489 News Found

Dr Reddy’s launch generic version of Vasostrict in the US
Drug Approval | February 09, 2022

Dr Reddy’s launch generic version of Vasostrict in the US

The Vasostrict brand market had U.S. sales of approximately US $ 878.5 million MAT for the most recent twelve months ending in December 2021 according to IQVIA Health


Azurity Pharma gets USFDA approval for Fleqsuvy
Drug Approval | February 08, 2022

Azurity Pharma gets USFDA approval for Fleqsuvy

Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%


USFDA approves first generic of Restasis
Drug Approval | February 03, 2022

USFDA approves first generic of Restasis

Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug


Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval
Biotech | February 01, 2022

Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval

Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel


USFDA approves Genentech’s Vabysmo to treat causes of vision loss
Drug Approval | January 31, 2022

USFDA approves Genentech’s Vabysmo to treat causes of vision loss

Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need


Israel signs deal to purchase Novavax’ Covid-19 vaccine
Biotech | January 29, 2022

Israel signs deal to purchase Novavax’ Covid-19 vaccine

It would be the first protein-based alternative available in Israel


Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy
Drug Approval | January 26, 2022

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy

Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Medtronic gets USFDA approval of spinal cord stimulation therapy
Medical Device | January 25, 2022

Medtronic gets USFDA approval of spinal cord stimulation therapy

Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types