The trial aims to measure AF burden—the percentage of time patients spend in arrhythmia—as its primary efficacy endpoint
Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
The work will leverage ProBioGen’s CHO.RiGHT expression platform, powered by its proprietary DirectedLuck transposase technology, alongside PsiBot smart automation
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
Rajdeep is an accomplished business leader with a strong techno-commercial background in the healthcare and diagnostic sector
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
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