Approvals

EC grants orphan drug status to Trovagene’s Onvansertib for AML treatment

Trovagene has announced that the European Commission (EC) has endorsed the positive opinion of the Committee for Orphan Medicinal Products (COMP) and granted orphan drug designation (ODD) for Onvansertib to treat patients with acute myeloid leukemia (AML).

Novartis’ Kymriah CAR-T cell therapy secures European approval

Novartis has secured the European Commission (EC) approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) for the treatment of B-cell acute lymphoblastic leukemia.

FDA approves Tetraphase’s Xerava for complicated intra-abdominal infections

Tetraphase Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI).

Bayer secures approval in EU for Xarelto for patients with coronary or peripheral artery disease

The European Commission (EC) has approved a combination of Xarelto (rivaroxaban) 2.5mg twice daily plus low dose aspirin (acetylsalicylic acid/ASA) once daily for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral arterial disease (PAD) at high risk of ischaemic events.

FDA approves Shire’s hereditary angioedema drug Takhzyro

Shire has secured approval from the US Food and Drug Administration (FDA) for Takhzyro (lanadelumab-flyo) injection as a preventative treatment of hereditary angioedema (HAE) in patients 12 years of age and older.

FDA approves Dompé’s Oxervate to treat neurotrophic keratitis

Dompé has secured approval from the US Food and Drug Administration (FDA) for its Oxervate (cenegermin-bkbj ophthalmic solution) to treat neurotrophic keratitis (NK).

Roche’s lung cancer drug Alecensa secures approval in China

Roche has secured marketing authorization from the China National Drug Administration (CNDA) for its Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive and advanced non-small cell lung cancer (NSCLC).

FDA approves Bristol-Myers’ Opdivo to treat metastatic SCLC

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's (BMS) Opdivo as the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.

Merck, Eisai win FDA approval for Lenvima to treat unresectable HCC

Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for kinase inhibitor Lenvima (lenvatinib) as the first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).