UK and EU regulatory agencies confirm COVID-19 Vaccine AstraZeneca is safe and effective

Today the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks.

Update on the safety of COVID-19 Vaccine AstraZeneca

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.

Further update on US regulatory review of roxadustat in anaemia of chronic kidney disease

AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for the treatment of anaemia of chronic kidney disease (CKD).

Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.