Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
Filing marks first protein-based vaccine submitted to MHRA for authorization
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The company proposes to invest up to US $ 50 million, over a period of five years, starting from FY22, to support capability development of talent and technology
If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence
It is a recombinant nanoparticle protein-based vaccine
CuraTeQ Biologics is on track for filing a second oncology biosimilar
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