European Medicines Agency (EMA)

New Capabilities

Assessing the safety reports

Nine children who received Zolgensma, a one-time gene therapy for spinal muscular atrophy, later developed tumors. In two of the three cases tested, Novartis found evidence the virus used to deliver the treatment had inserted itself into the patient's DNA.

Updated 5 days ago

New Capabilities

As of September 2026: Recommended approval of Ubeslo and Evlarco

The European Commission approved two obicetrapib-based cholesterol drugs on September 21, 2026. It's the first time any CETP inhibitor has reached the market, after Pfizer, Roche, Eli Lilly and Merck spent billions on the drug class and failed.

Updated Sep 21

New Capabilities

As of September 2026: Recommended approval of Zeydovio via its CHMP committee

Zealand Pharma's Zeydovio is one step from market in Europe. On September 17, the European Medicines Agency's scientific committee recommended approving the twice-weekly injection for adults with short bowel syndrome.

Updated Sep 20

New Capabilities

As of August 2026: 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

Rule Changes

As of May 2026: 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