A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme
The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies
Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain
BDR Pharmaceuticals is a home-grown company with operations in India and overseas. It’s known for its formulations portfolio and has a presence in specialty medicines. The company has ambitious plans as it has ramped up capacity and looking to foray into regulated markets. Raheel Shah, Director, BDR Group of Companies shares his insights in an interview with Thomas C Thottathil, Editor, Indian Pharma Post
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
Results from the ongoing vodobatinib clinical study are being presented for the second consecutive year at the ASH annual meeting, underlining the promising potential of the drug for the treatment of heavily pre-treated CML
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
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