Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Biosimilars For Avastin, Herceptin To Cap Off Busy July For ODAC
Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.
Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier
To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.