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Results For "Fast-Track-Designation"

61 News Found

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


Global Cord Blood Corp acquires Cellenkos to advance cell therapy market
Biotech | May 01, 2022

Global Cord Blood Corp acquires Cellenkos to advance cell therapy market

CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products


Oragnon enters global licencing agreement with Dare Biosciences
News | April 01, 2022

Oragnon enters global licencing agreement with Dare Biosciences

An estimated 21 million American women experience BV


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies


Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn
Biotech | December 22, 2021

Novartis to acquire Gyroscope Therapeutics for up to US $ 1.5 bn

Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy


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