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Results For "NIB"

173 News Found

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata
News | March 20, 2023

Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata

The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022


NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya
Policy | January 29, 2023

NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya

It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry


GSK’s new data underscore important responses with momelotinib for myelofibrosis patients
Diagnostic Center | December 12, 2022

GSK’s new data underscore important responses with momelotinib for myelofibrosis patients

48-week data from MOMENTUM phase III clinical trial show momelotinib maintained total symptom response


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