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Results For "clinical-evidence"

56 News Found

Glenmark Pharmaceuticals to launch DCGI-approved BRUKINSA in India for treatment of hematological malignancies
News | June 10, 2025

Glenmark Pharmaceuticals to launch DCGI-approved BRUKINSA in India for treatment of hematological malignancies

Globally, BRUKINSA is approved in more than 70 countries


Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved


NTC presents positive results from Phase II Mirakle study evaluating an innovative drug for bacterial conjunctivitis
News | December 07, 2024

NTC presents positive results from Phase II Mirakle study evaluating an innovative drug for bacterial conjunctivitis

Despite NTC014, due to its simplified therapeutic regimen, has been administered at a lower posology than the antibiotic comparator


GSK to acquire CMG1A46 from Chimagen Biosciences to expand immunology pipeline
News | November 01, 2024

GSK to acquire CMG1A46 from Chimagen Biosciences to expand immunology pipeline

CMG1A46 is an investigational T cell-engager with potential to deeply deplete uncontrolled B cells present in autoimmune diseases such as lupus


Suven Life Sciences announces FDA acceptance of investigational new drug
Drug Approval | August 30, 2024

Suven Life Sciences announces FDA acceptance of investigational new drug

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects


Sanofi reaffirms ambition to deliver >€10bn in annual vaccines sales by 2030
News | July 03, 2023

Sanofi reaffirms ambition to deliver >€10bn in annual vaccines sales by 2030

Intent to start at least 5 innovative Phase 3 vaccine programs by 2025


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


Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Drug Approval | February 23, 2023

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial