The ‘Global Goal: Unite for our Future’ pledging summitorganised today by the European Commission and Global Citizen mobilised €6.15 billion in additional funding to help develop and ensure equitable access to coronavirus vaccines, tests and treatments.
Earlier this week, intensive rains resulted in the largest flooding in the south-west of Ukraine in the last 50 years, with several casualties and damage to hundreds of homes.
The assessment of Member States’ first programmes of measures to control air emissions finds that the implementation of the new European clean air rules needs improvement.
EMA has recommended granting a conditional marketing authorisation in the European Union for Idefirix (imlifidase), the first treatment for adult patients waiting for a kidney transplant, who are highly sensitised against tissue from the donor and who have a positive crossmatch test against an available kidney from a deceased donor. Idefirix should be used complementary to […]
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, the first triple combination therapy for the treatment of cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del […]
The European medicines regulatory network has issued recommendations on impurities in medicines following the conclusion of an exercise to draw on lessons learnt from the presence of nitrosamines in a class of blood pressure medicines known as sartans. The recommendations aim to clarify the roles and responsibilities of companies involved in the manufacture of medicines […]
Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19 vaccine development and the necessary evidence required for regulatory decision-making at the second regulatory workshop on COVID-19 vaccines. The meeting was jointly organised by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on 22 […]
The additions include three substances that are toxic to reproduction and one endocrine disruptor. The Candidate List of substances of very high concern (SVHCs) now contains 209 substances that may have serious effects on people or the environment.
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed […]
Hungary and Ukraine will reopen all five of their road border crossings by Monday morning, Foreign Minister Péter Szijjártó said after talks with Dmytro Kuleba, his Ukrainian counterpart, and following the first meeting of the Hungarian-Ukrainian inter-governmental economic mixed committee in seven years, on which the two ministers signed a protocol.
