Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
09 Nov 2020
30 Oct 2020
GlaxoSmithKline (GSK) announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.
02 Sep 2020
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
28 Jul 2020
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.
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.