Horizon's Teprotumumab Breezes Through US FDA Adcom, But Safety Questions Remain
Executive Summary
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.
You may also be interested in...
Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions
FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.
Horizon Ramps Teprotumumab Launch Plans Into High Gear
With US FDA action on teprotumumab anticipated in March, Horizon has assembled a 100-person commercial team to begin educating physicians and payers on the rare autoimmune condition thyroid eye disease (TED).
Horizon's Poor Primary Care Performance Overshadows River Vision Buy
Horizon's deal to buy River Vision to bolster its orphan product pipeline is cast into the shade by a disappointing first quarter performance for its primary care business.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: