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 ...
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
15 September 2023 - Positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch ...
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
14 September 2023 - Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union ...
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
15 September 2023 - The EMA’s CHMP recommended nine medicines for approval at its September 2023 meeting. ...
15 September 2023 - Positive opinion based on Phase 3 ADAPT-SC study demonstrating non-inferior total IgG reduction at day 29 with ...