EMA

EMA Qualifies SV95C as a Digital Endpoint for DMD Trials

SV95C is approved by EMA as the digital primary endpoint for DMD trials

SG Tylor

Source – Sysnav Healthcare The European Medicines Agency (EMA) has granted approval for the utilization of a digital measurement employing ...

For its updated Covid-19 vaccine, Moderna submits a regulatory application to the European Medicines Agency

For its updated Covid-19 vaccine, Moderna submits a regulatory application to the European Medicines Agency

SG Tylor

Source – Moderna  On July 3, 2023 Moderna announced the submission of a regulatory application to the European Medicines Agency ...

Regulatory Update: Amylyx's ALS drug faces rejection by the European Medicines Agency (EMA)

Regulatory Update: Amylyx’s ALS drug faces rejection by the European Medicines Agency (EMA)

SG Tylor

Source – Amylyx Pharmaceuticals On June 23, 2023, the European Medicines Agency (EMA) has formally issued a negative opinion regarding ...