Medicines licensing

FDA approves first oral proteasome inhibitor for multiple myeloma

A new combination therapy for patients with multiple myeloma whose previous treatment has failed has been approved by the US Food and Drug Administration.…

First in class narcolepsy medicine recommended for approval in Europe

The first drug of its kind to treat patients with the rare but long-term sleep disorder narcolepsy is being recommended for use across the European Union.…

Clinical trial disclosures for new drugs are below legal and ethical standards, find researchers

Clinical trial disclosures for drugs approved by the US Food and Drug Administration fail to meet both the legal and ethical standards expected, according to research published in BMJ Open on 16 November 2015. …

Biosimilar medicines in rheumatology

The long-term safety of biosimilar medicines is unknown, but while their use in rheumatology practice is supported, switching patients currently responding and tolerating the reference product is not.…

FDA approves new HIV combination therapy designed to reduce side effects

A new HIV combination therapy for the treatment of adults and children aged over 12 years has been approved in the United States by the US Food and Drug Administration.…

FDA approves injectable monoclonal antibody for severe asthma

The US Food and Drug Administration has approved mepolizumab (GlaxoSmithKline’s Nucala), a humanized interleukin-5 antagonist monoclonal antibody, for use with other drugs to treat asthma in patients aged 12 years and over.…

Drug safety regulators endorse melanoma therapy derived from herpes virus

Patients with metastatic melanoma in the United States and Europe are set to have a new treatment option with a therapy derived from the herpes simplex virus.…

Cancer drugs approved on basis of trials with surrogate end points fail to improve survival

The US drugs regulator may be approving costly and toxic cancer drugs that fail to live up to expectations and do not improve survival rates, according to research published in JAMA Internal Medicine.…

FDA approves Factor X therapy for rare bleeding condition

The US Food and Drug Administration has approved a purified clotting factor for patients with hereditary Factor X deficiency.…

FDA approves idarucizumab as antidote to dabigatran

The US medicines safety watchdog has given fast-track approval to idarucizumab (Praxbind), a drug that can neutralise the effects of the anticoagulant dabigatran etexilate (Pradaxa).…