Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.
GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Mvasi (bevacizumab-awwb), a biosimilar to Roche's Avastin, to treat five types of cancer.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL).
Merck announced that the European Commission (EC) has granted marketing authorization for Mavenclad 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis*(RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.
Alexion Pharmaceuticals announced that the European Commission (EC) approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
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