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Results For "Phase-II"

570 News Found

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


CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares
News | October 17, 2022

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares

CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in


Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData
News | October 01, 2022

Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData

The booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.


Charsire's new drug aims to capture dementia treatment market
Biotech | September 22, 2022

Charsire's new drug aims to capture dementia treatment market

Charsire Biotechnology Corp. has successfully developed a revolutionary new drug (BAC) for Alzheimer's disease


Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
Drug Approval | September 21, 2022

Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19

Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial


Tezspire approved in the EU for the treatment of severe asthma
Drug Approval | September 21, 2022

Tezspire approved in the EU for the treatment of severe asthma

First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations


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.


USFDA approves first treatment option for generalized pustular psoriasis flares in adults
Drug Approval | September 03, 2022

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares