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 ...

MaaT Pharma (EURONEXT: MAAT ? the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for ...

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.

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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 ...

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 ...

NRXBF READ THE FULL NRXBF RESEARCH REPORT NurExone (OTC:NRXBF) is developing a product known as ExoPTEN that is designed to treat patients with acute spinal cord injuries, while also conducting ...

Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...