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Results For "Phase-II"

537 News Found

AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer
Clinical Trials | October 22, 2025

AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer

Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone


FDA approves Tezspire for chronic rhinosinusitis with nasal polyps
Drug Approval | October 21, 2025

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation


Roche to present latest cancer care data at ESMO 2025
Clinical Trials | October 13, 2025

Roche to present latest cancer care data at ESMO 2025

Roche will unveil the primary results from the phase III evERA Breast Cancer study evaluating giredestrant


AstraZeneca to unveil breakthrough cancer trial results at ESMO 2025
Clinical Trials | October 13, 2025

AstraZeneca to unveil breakthrough cancer trial results at ESMO 2025

The new data highlight the potential of AstraZeneca’s innovative therapies to improve outcomes across multiple cancer types


Datroway delivers first-ever overall survival breakthrough in 1st-line metastatic triple-negative breast cancer without immunotherapy
Clinical Trials | October 07, 2025

Datroway delivers first-ever overall survival breakthrough in 1st-line metastatic triple-negative breast cancer without immunotherapy

Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population


Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


Enhertu improved in invasive disease-free survival in early breast cancer in DB-05
Clinical Trials | September 29, 2025

Enhertu improved in invasive disease-free survival in early breast cancer in DB-05

Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting


AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1
Drug Approval | September 24, 2025

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population