Vaxzevria: EMA advises against use in people with history of capillary leak syndrome

11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...

Read more →

International regulators and WHO address need to boost COVID-19 vaccine confidence

11 June 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have jointly developed a statement ...

Read more →

Copiktra (duvelisib) receives European Union marketing authorisation for the treatment of relapsed or refractory CLL and refractory FL

9 June 2021 - Secura Bio today announced that on 19 May 2021, the European Medicines Agency granted marketing authorisation for ...

Read more →

Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union

7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...

Read more →

EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome

7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...

Read more →

Advancing international collaboration on COVID-19 real world evidence and observational studies

4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...

Read more →

EU regulators develop recommendations to forecast demand of medicines

3 June 2021 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a ...

Read more →

Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine

1 June 2021 - EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in ...

Read more →

EMA and EUnetHTA take stock of their co-operation

1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...

Read more →

Diurnal receives European Commission approval for Efmody

28 May 2021 - Commercial launch anticipated in Q3 2021. ...

Read more →

Calliditas announces submission of marketing authorisation application for Nefecon to the European Medicines Agency

28 May 2021 - Calliditas Therapeutics today announced that the company submitted a marketing authorisation application to the EMA for ...

Read more →

First COVID-19 vaccine approved for children aged 12 to 15 in EU

28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...

Read more →

Tagrisso approved in the EU for the adjuvant treatment of patients with early stage EGFR mutated lung cancer

28 May 2021 - Approval based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk ...

Read more →

Insufficient data on use of inhaled corticosteroids to treat COVID-19

27 May 2021 - EMA’s COVID-19 taskforce is advising health care professionals that there is currently insufficient evidence that inhaled ...

Read more →

EU seeks large AstraZeneca fine

26 May 2021 - A lawyer for the European Union has accused AstraZeneca of failing to respect its contract with ...

Read more →