Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from...
EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. The Committee recommended including...
UK – Grifols’ Tavlesse receives NICE recommendation
Therapy treats refractory chronic immune thrombocytopenia and is available across UK.
Grifols has announced that its treatment for adults with chronic immune thrombocytopenia (ITP), Tavlesse...
Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde...
Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande de nouvelles mesures pour réduire les risques d’insuffisance respiratoire et de sepsis...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease
The European Medicines Agency (EMA) has recommended a marketing authorisation in the European Union (EU) for Ebvallo (tabelecleucel) for the treatment of adult and paediatric...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...
Europe – Data Quality Framework for EU medicines regulation
As acknowledged in the recommendations of the HMA-EMA Joint Big Data Task Force (BDTF) and the workplan of the HMA-EMA Joint Big Data Steering...
Europe – High-quality data to empower data-driven medicines regulation in the European Union
EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the...
Europe – EMA Management Board: highlights of October 2022 meeting
COVID-19
At its 6 October 2022 meeting in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to...
UK – Bristol Myers Squibb’s active ulcerative colitis treatment bags NICE recommendation
The recommendation is specifically for patients who are intolerant of, or whose condition has had an inadequate response, or loss of response to previous...
