Resources, Guidelines, and Guidance Documents Directory

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Data from a Phase III study that evaluated lazertinib, in combination with amivantamab, in comparison to osimertinib as a first-line treatment resulted in the EC’s decision.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.