European Medicines Agency (EMA)

Stories

First Lyme disease vaccine in two decades edges toward approval after Phase 3 trial

Validated Pfizer-Valneva's Lyme vaccine marketing application on August 14, 2026; review expected to conclude within about 12 months

The vaccine, now formally designated PF-07307405 (also called LB6V, and previously known as VLA15), cleared its first regulatory hurdle since March's Phase 3 results. On August 14, 2026, the European Medicines Agency validated Pfizer and Valneva's marketing application, meaning the dossier is complete and formal review can begin.

Updated Aug 15

EU strikes landmark deal to rewrite its drug rulebook

Rule Changes

Preparing to implement streamlined structures and faster review processes under the new pharma package

After two years of trench warfare between EU governments, lawmakers and drug makers, Brussels has finally agreed a 'pharma package' that tears up the bloc's 20‑year‑old drug rules. The package locks in eight years of data protection, one year of market exclusivity, and bonuses extending to 11 years if companies meet public‑health goals.

Updated May 11