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).
05 Jun 2019
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.
11 Mar 2019
Roche has secured marketing authorization from the European Commission (EC) for its Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy for initial treatment of people with a specific type of metastatic lung cancer.
04 Mar 2019
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Pfizer’s Lorviqua (lorlatinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
05 Feb 2019
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Merck’s Keytruda plus chemotherapy to treat metastatic squamous non-small cell lung cancer (NSCLC).
04 Feb 2019
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s Forxiga (dapagliflozin) to treat adults with type-1 diabetes (T1D).
29 Jan 2019
Vertex Pharmaceuticals announced that Health Canada has granted Market Authorization for KALYDECO (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.