Pink Sheet reporters and editors discuss another explanation of the FDA’s Aduhelm label, the first lawsuit attempting to force the sale of samples for generic development, and the agency questioning promotion of Amgen’s Neulasta.

Pink Sheet reporters and editors discuss new Aduhelm documents explaining the FDA’s views on the accelerated approval, comments from the former FDA commissioner on his tenure and future, and options for improving advisory committee meetings.

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.