Marketing Authorisation

Janssen gets EC approval for subcutaneous use of daratumumab

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.

Sanofi secures EC approval for Sarclisa for third-line multiple myeloma

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.

Bristol Myers Squibb receives EC approval for Zeposia in adults with RRMS with active disease

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.

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).

Takeda gets EU approval for ALUNBRIG in ALK+ NSCLC

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.

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.

Alnylam gets EC nod for Givlaari to treat acute hepatic porphyria

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.

Pfizer’s VYNDAQEL gets EC approval for treatment of ATTR-CM

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).

Bristol-Myers Squibb withdraws European application of Opdivo plus Yervoy for first-line treatment of advanced NSCLC

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the company has withdrawn its application in the European Union (EU) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.