The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, del
Shares in Minerva Neurosciences have lost more than half their value after the FDA rejected its marketing application for roluperidone as a treatment for the negative symp
For the first time, pharmacists in the US will be able to substitute a cheaper biosimilar version when they receive a prescription for AbbVie’s high-concentration formulat
In an unusual move, United Therapeutics has filed a lawsuit against the FDA that claims the regulator is sidestepping established norms in allowing rival Liquidia to file
Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people w