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Results For "phase-3"

686 News Found

Sanofi updates on amcenestrant clinical development program
Clinical Trials | August 18, 2022

Sanofi updates on amcenestrant clinical development program

The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial


FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval | August 09, 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy


LYNPARZA approved in the EU as adjuvant treatment for early breast cancer
Drug Approval | August 04, 2022

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Novartis data show nearly 80% of RMS patients treated with ofatumumab had no evidence of NEDA-3
News | June 29, 2022

Novartis data show nearly 80% of RMS patients treated with ofatumumab had no evidence of NEDA-3

Earlier initiation with Kesimpta resulted in a more than three-fold increased likelihood of maintaining NEDA-3 throughout the study


Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer
Drug Approval | June 28, 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients


Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Drug Approval | June 23, 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients


FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Drug Approval | June 14, 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial


Sanofi-GSK next-gen COVID-19 booster delivers strong immune response against main variants
News | June 14, 2022

Sanofi-GSK next-gen COVID-19 booster delivers strong immune response against main variants

Next-generation booster vaccine candidate demonstrates potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile