EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
The validations confirm the completion of the applications and commence the scientific review process
The validations confirm the completion of the applications and commence the scientific review process
Acquisition of exclusive commercialization rights for European markets
The observations do not pose any risk to site's compliance standards or its business continuity
Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA
Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Agreed Price of US$43 per share to deliver 48% premium to unaffected price on May 25, 2023
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
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