The US Food and Drug Administration’s (FDA) division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Akcea Therapeutics' Waylivratm (volanesorsen) for the treatment of familial chylomicronemia syndrome (FCS).
The US Food and Drug Administration (FDA) has approved Relypsa’ supplemental new drug application (sNDA) for Veltassa (patiromer) for oral suspension in the treatment of hyperkalemia, or elevated blood potassium levels.
Roche’s cancer immunotherapy Tecentriq (atezolizumab) in combination with chemotherapy has been granted priority review in the US for the treatment of a specific type of metastatic lung cancer.
Novartis Pharmaceuticals has secured approval from the US Food and Drug Administration for its Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy to treat anaplastic thyroid cancer (ATC).
Novartis has secured a second approval for Kymriah (tisagenlecleucel) in the US for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma who had more than two lines of systemic therapy.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tagrisso (osimertinib) to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.
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