Drug Approval | August 29, 2022
Lupin receives tentative approval from USFDA for Dasatinib Tablets
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
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
Blood contains a mixture of exosomes secreted from nearly all tissues and cells, and exosomes from other tissues can mask changes caused by disease, making it difficult to detect the presence of biomarkers that reflect disease
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
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
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