Clinical Trial Authorisation

FDA Fast Track designation for Parkinson’s Disease treatment

20 July 2021

BlueRock Therapeutics has been granted Fast Track designation by the US Food and Drug Administration (FDA) for DA01 for advanced Parkinson’s disease (PD). DA01, BlueRock’s pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase I study. “Receiving Fast Track Designation from the FDA is an important step, which will help us further […]

Moderna initiates rolling submission of Biologics License Application (BLA)

2 June 2021

Moderna has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older. Stéphane Bancel, Chief Executive Officer of Moderna, said: “We look forward to working with the FDA […]

Avacta announces Phase I Clinical Trial Authorisation (CTA) for AVA6000

18 February 2021

Avacta, the developer of Affimer biotherapeutics and reagents, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK for a Phase I study of its lead pre|CISION pro-drug, AVA6000 pro-doxorubicin. In AVA6000, doxorubicin has been modified with Avacta’s pre|CISION chemistry, which renders the modified […]