12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
25 September 2023 - Conditional marketing authorisation approval from the European Commission is supported by data from the pivotal Phase 1/2 ...
21 September 2023 - Jazz Pharmaceuticals today announced that the European Commission has granted marketing authorisation for Enrylaze (JZP458; a recombinant ...
19 September 2023 - Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral ...
19 September 2023 - European Commission approves Tevimbra for previously treated advanced or metastatic oesophageal squamous cell carcinoma. ...
20 September 2023 - Biocon Biologics, a subsidiary of Biocon, has announced that the European Commission granted marketing authorisation in ...
20 September 2023 - Orserdu is the first treatment specifically for patients with oestrogen receptor positive, HER2 negative advanced or metastatic breast ...
18 September 2023 - Takeda announced today that the CHMP of the EMA has adopted a positive opinion for the ...
19 September 2023 - This positive opinion reinforces Veklury’s strong safety profile. ...
19 September 2023 - Tyenne is the first tocilizumab biosimilar approved by the European Commission. ...
19 September 2023 - Otsuka and Astex Pharmaceuticals today announce that the European Commission has approved Inaqovi (oral decitabine and ...
19 September 2023 - Pfizer today announced that the European Commission has granted marketing authorisation for Litfulo (ritlecitinib) to treat adults ...
15 September 2023 - Positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch ...
14 September 2023 - Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union ...