Regulation

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 turns down Lipocine’s application for oral testosterone product Tlando

The US Food and Drug Administration (FDA) has refused to approve Lipocine's Tlando, an oral testosterone product candidate for testosterone replacement therapy (TRT).

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.

Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA

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).