The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European ...

Mía had dystrophic epidermolysis bullosa, better known as butterfly skin due to the extreme fragility of this tissue in ...

This approval marks a major regulatory milestone ... The PDCO issues an opinion on PIP as part of the regulatory process and the EMA adopts a final decision based on the PDCO's opinion.

Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not ...

In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage ...

So for the FDA, the time of approval as the endpoint for market authorization is appropriate. In Europe, the EMA's process involves one more step, creating an intermediate time point that seems to ...

The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...

Getting patients access to treatments they need – without which they will die – is the ‘biggest burden of my life’, says Prof ...