Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO
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
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