Novartis has secured approval from the European Commission (EC) for Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.
Novartis has secured approval from the European Commission (EC) for its Gilenya (fingolimod) to treat children and adolescents, aged between 10 and 17 years, with relapsing-remitting forms of multiple sclerosis (RRMS).
Teva Pharmaceutical and Celltrion have secured approval from the US Food and Drug Administration (FDA) for Truxima (rituximab-abbs), a biosimilar to Roche’s cancer drug Rituxan (rituximab), for three non-Hodgkin’s lymphoma indications.
The Mundipharma network of independent associated companies has secured approval from the European Commission (EC) for its Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy for chemotherapy.
The European Commission (EC) has approved Camurus’ weekly and monthly Buvidal (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age.
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Daurismo (glasdegib) to treat adult patients with newly-diagnosed acute myeloid leukemia (AML) for whom intensive chemotherapy is not an option.
Takeda Pharmaceutical has secured clearance from the European Commission (EC) for its proposed $62bn acquisition of Shire.
Swedish Orphan Biovitrum (Sobi) and Novimmune have secured approval from the US Food and Drug Administration (FDA) for their monoclonal antibody Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH).
The US Food and Drug Administration (FDA) has approved Aries Pharmaceuticals’ Aemcolo (rifamycin) 194mg delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for the treatment of adult patients with Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli.
The US Food and Drug Administration (FDA) has expanded the label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST).
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