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
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine
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
If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option
Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality
Importantly, the combination of giredestrant and everolimus was well tolerated
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
Collaboration matches more eligible patients, including those with rare and complex diseases, to appropriate clinical trials
IND application for EB-003 expected in early 2026
Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo
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