Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The Board of Directors of Caplin Point Laboratories at its meeting have approved the unaudited consolidated financial results of the company for the period ended September 30, 2021
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
FDI increased 98% year on year in 2020 and pharma exports grew by 18% in the last financial year
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 BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level
Industry leaders to increase patient access to clinical research and scale remote enrollment of participants for trial sponsors to promote increased health equity
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