Briefing materials released before Wednesday's panel review indicate the regulator wants clearer data to assess Amgen's experimental melanoma treatment.
The drugmaker said its top-selling multiple-sclerosis drug Tecfidera's slowdown in sales is due to competition from Plegridy as well as new patient concerns about risks of a rare brain infection.
The drugmaker touted new data for its doublet regimen at the International Liver Congress, but it will likely have to look to the margins to find an underserved patient population.
A more general warning encourages consumers to engage in a personal discussion with their doctor about a drug, and it promotes engagement with longer-format printed or digitally-delivered information.
Apple is putting the power of clinical trials in our pockets with ResearchKit.
Why healthcare brands need to start speaking in video, and how they can do it