Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B

28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...

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Highlights from CHMP 24-27 January meeting

28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...

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COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched

25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...

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Vyepti (eptinezumab) approved by the EU Commission for the preventive treatment of migraine in adults

24 January 2022 - Vyepti is the first intravenous treatment approved for migraine prevention in Europe. ...

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EMA publishes agenda for 24-27 Jan CHMP meeting

23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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International regulators’ recommendations on COVID-19 vaccines and the Omicron variant

21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...

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ChemoCentryx announces EU approval of Tavneos (avacopan) for the treatment of ANCA associated vasculitis

19 January 2022 - ChemoCentryx today announced that Tavneos (avacopan) has been approved within the European Union in combination with a ...

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COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy

18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...

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Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity

14 January 2022 -  Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...

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Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency

13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...

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Accelerating clinical trials in the EU: for better clinical trials that address patients’ need

13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...

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Global regulators discuss path towards regulatory alignment on response to Omicron variant

13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...

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Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant

11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...

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European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years

11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...

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