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Results For "NIB"

303 News Found

Eugia Pharma signs voluntary license with Medicines Patent Pool to develop generic version of Nilotinib Capsules
News | June 24, 2023

Eugia Pharma signs voluntary license with Medicines Patent Pool to develop generic version of Nilotinib Capsules

The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India


Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST
Biotech | June 03, 2023

Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors


Hutchmed completes rolling submission of NDA to USFDA for fruquintinib
Drug Approval | April 03, 2023

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib

NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China


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
Clinical Trials | 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.