Following mixed results from two Phase III trials, the company plans to consult FDA on next steps.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
