Celltrion Healthcare has secured approval from the European Commission (EC) for the subcutaneous (SC) formulation of autoimmune disease drug Remsima (infliximab, CT-P13) for the treatment of five more indications.
28 Jul 2020
29 Jun 2020
EC approves Reblozyl for transfusion-dependent anemia in myelodysplastic syndromes or beta thalassemia
Bristol Myers Squibb and Acceleron Pharma announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:
05 Jun 2020
Johnson & Johnson’s Janssen Pharmaceutical has secured approval from the European Commission for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of multiple myeloma in adult patients.
03 Jun 2020
Sanofi has secured approval from the European Commission (EC) for Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of relapsed and refractory multiple myeloma (MM) in adult patients.
28 May 2020
Bristol Myers Squibb announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
11 May 2020
EC approves subcutaneous formulation of Entyvio as maintenance therapy in ulcerative colitis or Crohn’s disease
Takeda Pharmaceutical announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
07 Apr 2020
Takeda Pharmaceutical has secured expanded approval for ALUNBRIG (brigatinib) in the European Union (EU) to use the tyrosine kinase inhibitor for the treatment of a particular lung cancer population.
09 Mar 2020
AbbVie receives marketing authorisation from EC to shorten MAVIRET duration for treatment-naïve genotype 3 HCV patients with compensated cirrhosis
AbbVie said that the European Commission has approved a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.
04 Mar 2020
Alnylam Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for its Givlaari (givosiran) to treat acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
19 Feb 2020
Pfizer has secured European approval for its oral transthyretin stabilizer VYNDAQEL (tafamidis) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).