Amgen, UCB are back pitching once-rejected osteoporosis drug romo to the FDA — but big hurdles lie ahead

Amgen, UCB are back pitching once-rejected osteoporosis drug romo to the FDA — but big hurdles lie ahead

Source: 
Endpoints
snippet: 

Romosozumab is back.

Almost exactly a year after Amgen $AMGN and its partners at UCB were handed a rejection on the osteoporosis drug, they’ve repackaged their application according to the agency specs and will now take another run at an approval.