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

594 News Found

USFDA approves Lupin’s Supplemental New Drug Application for Solosec
Drug Approval | February 17, 2022

USFDA approves Lupin’s Supplemental New Drug Application for Solosec

The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV


USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years


Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19
Drug Approval | February 14, 2022

Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19

Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data


USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Drug Approval | February 10, 2022

USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences

Adds five years of market exclusivity on approval


Gamida Cell initiates rolling submission of Biologics License Application for Omidubicel
Biotech | February 10, 2022

Gamida Cell initiates rolling submission of Biologics License Application for Omidubicel

On track to complete the BLA submission in the first half of 2022


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