Approvals

Ipsen’s Cabometyx secures approval in Europe for first-line kidney cancer

The European Commission (EC) has approved Ipsen’s Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate or poor- risk advanced renal cell carcinoma (aRCC).

Novartis and Amgen secure FDA approval for migraine drug

Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.

FDA expands approval of Novartis’ Gilenya to treat MS in pediatric patients

Novartis has secured an expanded approval of Gilenya (fingolimod) in the US for the treatment of children and adolescents, in the age group of 10-18 years, with relapsing forms of multiple sclerosis (RMS).

FDA committee recommends approval of Akcea’s FCS drug

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).

FDA approves updated label of Relypsa’s Veltassa hyperkalemia drug

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 Tecentriq combo gets FDA priority review to treat lung cancer

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’ Tafinlar/Mekinist combo gets FDA nod for anaplastic thyroid 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).

FDA expands approval of Novartis’ Kymriah CAR-T therapy

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.

AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC

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.