When J&J Eliminates the Interim: What the NANORAY-312 Amendment Actually Signals
J&J's FDA-accepted protocol amendment to NANORAY-312 drops the interim analysis for NBTXR3—here's what that move reveals about pivotal trial...
FDA Regulatory Strategy
Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...
EU Clinical Trials Face Cost, Speed, and China Competition Pressure
At the Clinical Trial Innovation Summit 2025 in Basel, industry leaders from UCB, Novo Nordisk, Novartis, and Medable debated...
France Just Approved What the U.S. Still Won’t Name: IV Ketamine for Acute Suicidal Crisis
France's March 2026 approval of intravenous racemic ketamine for severe suicidal crisis is the first regulatory action of its...
France Approved IV Ketamine for Suicidal Crisis. The FDA Should Be Uncomfortable Right Now.
France's March 2026 authorization of intravenous racemic ketamine for acute suicidal crisis is the first regulatory approval of its...
The EMA’s Virtual Control Group Gambit Could Redraw the Map for Pivotal Trial Design
The EMA has opened consultation on a draft qualification opinion for virtual control groups — a methodology that, if...
The Trial That Should Rewrite the Rare Disease Playbook — But Probably Won’t
AstraZeneca's Phase 3 benralizumab trial in hypereosinophilic syndrome just delivered one of the cleanest efficacy signals in rare disease...
The Wearable Gap: Why Sensors Are Outrunning the Trials That Use Them
Wearables are generating physiological data at a scale clinical trials have never seen before. But a March 2026 review...
Bourla vs. Prasad: Is Pfizer Defending Science or Defending Its Pipeline?
When Pfizer CEO Albert Bourla publicly calls out a sitting FDA division chief by name, the instinct is to...