Valneva SE confirmed that the European Medicines Agency accepted the filing of a marketing authorization application (MAA) for the specialty vaccine company’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001.
The European Medicines Agency on March 25 recommended the use of Johnson & Johnson and partner Legend Biotech Corp.’s CAR-T therapy Carvykti to treat multiple myeloma, nearly a month after the treatment was cleared in the United States.
EU health agencies recommended that Covid-19 vaccines be mixed and matched for both initial courses and booster doses as the region battles rising cases ahead of Christmas.
The European Union’s drug regulator on November 19 advised that an experimental Covid-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
The European Commission (EC) granted marketing authorization for Biogen Inc.’s Vumerity (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
AstraZeneca and the European Commission reached a settlement on the delivery of 200 million pending Covid-19 vaccine doses by the drugmaker, ending a row about shortages that had weighed on the company and the region’s vaccination campaign.
AstraZeneca’s top-selling Tagrisso drug was approved for use in the European Union to treat patients with a type of early-stage lung cancer, the company said on May 28.
AstraZeneca Plc’s Imfinzi was approved in the European Union to treat an aggressive form of lung cancer in previously untreated adult patients.
As pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.