New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include seven new products, including the COVID-19 vaccines from AstraZeneca/Oxford University and Moderna respectively. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).

The Pink Sheet’s regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure now includes seven new products – COVID-19 Vaccine AstraZeneca, Enhertu, Elzonris, Xofluza , COVID-19 Vaccine Moderna, Libmeldy, and Tecartus.

The great majority of new, innovative medicines and vaccines that are marketed in the EU go through the centralized procedure....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

New EU Filings

13 Aug 2025

• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

13 Aug 2025

• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.