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
The Phase II study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of 9MW3811 in patients with pathological scarring
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
The approval is supported by data from three pivotal clinical trials
Elanco expects Befrena to launch in the US in the first half of 2026
Coverage has been significantly strengthened across key therapeutic categories, including anti-tubercular, anti-diabetic and anti-cancer medicines, as well as iron supplements, thereby ensuring more comprehensive standardisation of medicines used under various National Health Programmes
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 decision secures legal protection in China for semaglutide, the blockbuster drug underpinning Novo Nordisk’s diabetes and obesity treatments
The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
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