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Results For "Food-and-Drug-Administration"

1255 News Found

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


USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test
Healthcare | February 15, 2022

USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test

Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation


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%


Lupin receives approval from USFDA for Arformoterol Tartrate inhalation
Drug Approval | February 08, 2022

Lupin receives approval from USFDA for Arformoterol Tartrate inhalation

Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)


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