Drug Approval | January 05, 2026
FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
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
Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety
He noted the enduring relevance of Siddha medicine as “a comprehensive, preventive and sustainable healthcare system in the contemporary world
The approval is supported by data from three pivotal clinical trials
Leaders from science, policy, industry, and investment came together in New Delhi to examine how alignment across the biotechnology value chain can turn innovation into outcomes at scale
The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
The accelerated review covers WCK 5222 for multiple critical infections
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
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