The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
First results demonstrate favourable tolerability of TQL-1055 at all dose levels
The company recently raised US $ 2.25 million seed round and the app was CE-Certified as a medical device in Europe
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor
The company is eligible for 12 months exclusivity from launch
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine
Preclinical and early human data indicate BriLife may confer enhanced immunity against Delta variant
Filing for WHO Emergency Use Authorisation this month
AstraZeneca, Sinopharm and Moderna were part of the study
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