regulatory

News

Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.

R&D

The future of drug development is not scientists versus algorithms. It is scientists and algorithms working together.

Market Access

For US drug developers, bringing AI tools across the Atlantic introduces steep regulatory hurdles.

Patients

A medicine can be nationally recommended and still be difficult to access if local systems are not ready to identify, offer, deliver, and monitor it.

News

After reporting mixed clinical results in a phase 3 trial, Pfizer and Valneva have filed their Lyme disease vaccine candidate PF-07307405 in the EU.

News

ITM's first attempt to score FDA approval for one of its radiopharma therapies has been knocked back by the agency.