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Results For "Phase-II"

570 News Found

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


AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps
News | September 23, 2025

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent


Ascletis reports positive phase Ib results for oral GLP-1R agonist ASC30 at EASD 2025
Clinical Trials | September 19, 2025

Ascletis reports positive phase Ib results for oral GLP-1R agonist ASC30 at EASD 2025

The Phase Ib MAD study is a randomized, double-blind, placebo-controlled trial conducted in the United States


Ascletis' ASC30 obesity drug shows 75-day half-life in US Study
Clinical Trials | September 16, 2025

Ascletis' ASC30 obesity drug shows 75-day half-life in US Study

Ascletis announces ultra-long-acting subcutaneous depot maintenance formulation of small molecule GLP-1R agonist ASC30 with 75-Day observed half-life in participants with obesity


Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran
News | August 31, 2025

Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran

Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives


Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China
News | August 30, 2025

Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China

Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)


Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr
News | August 13, 2025

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY