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Results For "Phase-II"

537 News Found

European Commission approves SPEVIGO for generalized pustular psoriasis flares
Drug Approval | December 13, 2022

European Commission approves SPEVIGO for generalized pustular psoriasis flares

EC grants conditional marketing authorization based on the EFFISAYIL trial


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


Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022
Clinical Trials | December 12, 2022

Roche presents new data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022

Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes


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


Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
News | December 01, 2022

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.


EMPA-KIDNEY trial showed significant benefit of Jardiance in reducing kidney disease progression
Clinical Trials | November 07, 2022

EMPA-KIDNEY trial showed significant benefit of Jardiance in reducing kidney disease progression

Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


Aragen to operationalize Hyderabad formulation manufacturing facility by Jan 2023
News | October 21, 2022

Aragen to operationalize Hyderabad formulation manufacturing facility by Jan 2023

The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting