Keeping Track: Accelerated Approval For Tecentriq And A Burst Of Filings And Submissions
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
You may also be interested in...
MEI Gets Another Chance At PI3K Inhibitor With Infinity Merger
Merger plans follow MEI’s recent decision to shelve its own PI3K inhibitor due to class safety concerns. Combined firm will have three clinical oncology candidates, runway into 2025.
Genentech’s Hopes For Keeping Tecentriq Breast Cancer Claim May Rest With Trial In Early Disease Recurrence
Even though IMpassion132 is enrolling a different population and has a different chemotherapy backbone, it could confirm atezolizumab’s benefit for patients with advanced triple-negative breast cancer whose tumors express PD-L1, agency says ahead of advisory committee meeting on accelerated approval indications with failed confirmatory trials.
Keeping Track: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta
The latest drug development news and highlights from our US FDA Performance Tracker.