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Results For "Fast-Track-Designation"

36 News Found

Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery
Drug Approval | November 30, 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal


Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction


Cadila Healthcare net profit at Rs 587.2 cr in Q1FY22
News | August 11, 2021

Cadila Healthcare net profit at Rs 587.2 cr in Q1FY22

The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine


EMA grants ODD to Saroglitazar Mg
News | July 21, 2021

EMA grants ODD to Saroglitazar Mg

Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC