Merck, known as MSD outside the US and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1).
21 Nov 2019
28 Oct 2019
Astellas Pharma’s Xospata (gilteritinib) has secured approval from the European Commission (EC) as a monotherapy for the treatment of acute myeloid leukaemia (AML).
29 Jul 2019
Roche’s Tecentriq (atezolizumab) and chemotherapy combination has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of two types of lung cancer.
04 Jul 2019
ViiV Healthcare has secured marketing authorisation from the European Commission (EC) for its Dovato (dolutegravir/lamivudine) to treat HIV-1 infection.
03 Jul 2019
Sanofi and Regeneron Pharmaceuticals have been given conditional approval by the European Commission (EC) for their fully-human monoclonal antibody Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.
05 Jun 2019
bluebird bio has secured conditional marketing authorisation from the European Commission (EC) for its one-time gene therapy ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene) for the treatment of transfusion-dependent β-thalassemia (TDT).
29 May 2019
Santhera Pharmaceuticals has filed a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD).
29 Apr 2019
Pfizer receives positive CHMP opinion for TALZENNA for patients with inherited BRCA-mutated locally advanced or metastatic breast cancer
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU).
11 Apr 2019
The European Commission has expanded the approval of AstraZeneca and MSD’s Lynparza (olaparib) to cover the treatment of a form of advanced breast cancer.
15 Mar 2019
European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
Roche announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.