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Results For "NIB"

134 News Found

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

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


Quizartinib granted priority review in the U.S.
Drug Approval | October 26, 2022

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone


InnoCare announces priority review of Orelabrutinib for the treatment of R/R MZL by NMPA
News | September 06, 2022

InnoCare announces priority review of Orelabrutinib for the treatment of R/R MZL by NMPA

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.


Lupin receives tentative approval from USFDA for Dasatinib Tablets
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).


Dr. Reddy's Lab launches sorafenib tablets in US
News | June 15, 2022

Dr. Reddy's Lab launches sorafenib tablets in US

Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.


Alembic receives USFDA tentative approval for Dasatinib tablets
Drug Approval | June 12, 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive


Quizartinib Plus chemotherapy significantly improved overall survival compared to chemo
News | June 12, 2022

Quizartinib Plus chemotherapy significantly improved overall survival compared to chemo

Doubling of median overall survival seen in QuANTUM-First results presented at EHA Presidential Symposium


New two-year Deucravacitinib data show promising results for severe plaque psoriasis
Biotech | May 12, 2022

New two-year Deucravacitinib data show promising results for severe plaque psoriasis

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


Juniper Biologics signs exclusive license agreement with Helsinn for infigratinib (INN) for the emerging markets including India
Biotech | May 04, 2022

Juniper Biologics signs exclusive license agreement with Helsinn for infigratinib (INN) for the emerging markets including India

Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication


Intas and Axantia sign an exclusive agreement for Ranibizumab biosimilar
Biotech | April 04, 2022

Intas and Axantia sign an exclusive agreement for Ranibizumab biosimilar

Intas has developed a biosimilar of Lucentis, which is currently under Phase III global trial for submission in major countries including EMA & the US