8 source-based articles maintained by the HealthRX.com Editorial Team.
Showing 8 of 8 clinical reviews.
A complete regulatory history of Cialis (tadalafil), covering FDA approval, EMA authorization, generic entry, label updates, and global post-market surveillance data.
A side-by-side comparison of how the FDA and EMA approved, labeled, and monitor tadalafil (Cialis), including indication scope, dosing, safety signals, and post-market surveillance differences.
A clinical review of tadalafil (Cialis) compounding legality under FDA 503A and 503B frameworks, patent expiry implications, and how patients can safely access compounded tadalafil in 2026.
A clinician-focused review of Cialis (tadalafil) FAERS safety signals, FDA label history, post-market surveillance data, and what the adverse event database reveals about real-world risk.
A complete regulatory timeline of tadalafil (Cialis): original FDA approval dates, indication expansions, label revisions, post-market safety signals, and what the current prescribing information requires.
Complete history of Cialis (tadalafil) legal battles, patent disputes, FDA approval milestones, and regulatory actions from 2003 through generic entry.
A clinical review of tadalafil's FDA approval history, current label indications, post-market safety data, patent field, and next-generation PDE5 inhibitor pipeline developments.
No new black box warning, but tadalafil's label added stronger hearing loss and NAION warnings, revised renal dosing, and SGLT2 interaction data.