Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate.
The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and Health Sciences Authority in Singapore — and it intends to seek prequalification (PQ) and/or emergency use listing (EUL) with the World Health Organization.
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