EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
Doubling of median overall survival seen in QuANTUM-First results presented at EHA Presidential Symposium
Deucravacitinib is currently under regulatory review in multiple regions, including the U.S., Europe and Japan, and would be the first selective allosteric tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of any disease
Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication
Intas has developed a biosimilar of Lucentis, which is currently under Phase III global trial for submission in major countries including EMA & the US
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