Ten Years of EMA Post-Authorization Data Reveal a System Running on Incomplete Evidence
A Nature Reviews Drug Discovery analysis of EMA post-authorization studies exposes systematic gaps in how conditional approvals convert to...
FDA Regulatory Compliance
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...
Greenwich LifeSciences Switched Drug Product Mid-Pivotal Trial. The FDA Has Rules About That.
Greenwich LifeSciences announced mid-trial use of commercially manufactured GP2 in its Phase III FLAMINGO-01 study. What looks like a...