The Story of Aduhelm, From Early Studies To Commercial Demise
Our graphical timeline walks you through the most significant events in the history of the Alzheimer’s drug, including the tumultuous last year.
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Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.
Acknowledging the toll that vaccine opponents have taken on FDA operations, the CBER director emphasizes the need to create stand-by manufacturing capacity, conduct faster studies in special populations, and better understand the mRNA platform.
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.