Approvals

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes.

FDA approves Lilly’s Taltz for treatment of ankylosing spondylitis

Eli Lilly and Company (Lilly) has secured approval for its monoclonal antibody Taltz (ixekizumab) from the US Food and Drug Administration (FDA) for the treatment of active ankylosing spondylitis (AS) in adults.

GSK’s belantamab mafodotin meets primary objective in multiple myeloma trial

GlaxoSmithKline’s (GSK) immuno-conjugate belantamab mafodotin (GSK2857916) has achieved its primary objective in the multiple myeloma trial.

FDA grants fast track status to Moderna’s Zika vaccine

Moderna, a biotechnology company, has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational Zika vaccine, mRNA-1893.

AbbVie receives FDA approval of RINVOQ for moderate to severe rheumatoid arthritis

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

Celgene’s Inrebic gets FDA approval for myelofibrosis

Celgene has secured approval from the US Food and Drug Administration (FDA) for its Inrebic (fedratinib) to treat adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

Roche gets FDA nod for Rozlytrek to treat ROS1-positive NSCLC

Roche has secured approval from the US Food and Drug Administration (FDA) for its Rozlytrek (entrectinib) to treat adults with ROS1-positive and metastatic non-small cell lung cancer (NSCLC).

Janssen gets EC approval for two new indications of Imbruvica

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the European Commission (EC) for two new indications of Imbruvica (ibrutinib).

FDA approves Daiichi Sankyo’s Turalio for rare joint tumour

Daiichi Sankyo has secured approval from the US Food and Drug Administration (FDA) for the use of Turalio (pexidartinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).