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Results For "Food-and-Drug-Administration"

1017 News Found

Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Boehringer Ingelheim gets CDSCO nod for Jardiance
Drug Approval | November 23, 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease


Amneal gets approval for Difluprednate ophthalmic emulsion
Drug Approval | November 22, 2021

Amneal gets approval for Difluprednate ophthalmic emulsion

The company is moving towards complex and more differentiated products


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


U.S. FDA allows Pfizer and Moderna booster doses for all
News | November 20, 2021

U.S. FDA allows Pfizer and Moderna booster doses for all

This is a shot in the arm for the vaccine manufacturers


U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism
Drug Approval | November 20, 2021

U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth


Novavax and Serum Institute receive EUA for Covovax
News | November 18, 2021

Novavax and Serum Institute receive EUA for Covovax

The vaccine will be manufactured and marketed in the Philippines by SII under the brand name Covovax


Roche launches cobas 5800, a new molecular diagnostics system
Digitisation | November 18, 2021

Roche launches cobas 5800, a new molecular diagnostics system

The system is a compact new addition to the Roche Molecular portfolio, providing efficiency, simplicity and timely results to laboratories of all sizes.


US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment
Biotech | November 18, 2021

US govt signs deal with GSK and Vir Biotechnology to buy sotrovimab, a Covid-19 treatment

The final data from the trial showed sotrovimab reduces hospitalisation and risk of death by 79% in adults with mild-to-moderate Covid-19 who are at high risk of progression to severe disease