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).
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.
The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing approval from the European Commission (EC) for Erleada (apalutamide) to treat non-metastatic castration-resistant prostate cancer (nmCRPC).
Zydus Cadila, an Indian pharmaceutical company, has obtained final approval from the US Food and Drug Administration (FDA) to market Clindamycin Phosphate and Benzoyl Peroxide Gel.
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).
Swissmedic has granted marketing authorization for Octapharma’s new fibrinogen concentrate product fibryga for the treatment of congenital and acquired fibrinogen deficiencies.
Spark Therapeutics and Novartis have secured the approval from the European Commission (EC) for their one-time gene therapy Luxturna (voretigene neparvovec) to treat patients with a rare inherited form of vision loss that could lead to blindness.
AbbVie and Roche have secured approval from the European Commission (EC) for the combination of Venclyxto (venetoclax) and MabThera (rituximab) to treat relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL) in adult patients who had received at least one prior therapy.
Vertex Pharmaceuticals (Europe) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Kalydeco (ivacaftor) to treat people with cystic fibrosis (CF) aged 12 to <24 months with certain mutations in the CFTR gene.
GlaxoSmithKline (GSK) and Innoviva secured positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the expanded use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol FF/UMEC/VI) in moderate to severe chronic obstructive pulmonary disease (COPD).
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