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Results For "clinical"

2985 News Found

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


BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease


Takeda exits cell therapy research
R&D | October 05, 2025

Takeda exits cell therapy research

Takeda will seek an external partner to leverage its cell therapy platform technologies


Amgen’s Phase III data supports FDA label expansion of Repatha
News | October 05, 2025

Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention


Genmab to acquire Merus for $8 billion
News | October 03, 2025

Genmab to acquire Merus for $8 billion

Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio


Novartis to launch DTP platform for Cosentyx in US
Supply Chain | October 01, 2025

Novartis to launch DTP platform for Cosentyx in US

Through the new DTP platform, Novartis will make Cosentyx available to patients at a price that reflects the average savings typically retained by insurers and pharmacy benefit managers


Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial
Clinical Trials | October 01, 2025

Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial

Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine