US Food and Drug Administration (FDA)

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.…

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 issues safety warning about AbbVie’s hepatitis C treatments

The US Food and Drug Administration has issued a safety warning about two hepatitis C treatments, which it says can cause serious liver injury and can result in death.…

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).…

FDA fast tracks nivolumab for advanced non-squamous non-small cell lung cancer

The US drugs safety regulator has fast-tracked the approval of nivolumab to extend its current use to a new group of patients with advanced lung cancer.…

Fears over cancer risk with MS drug cladribine unfounded

Cladribine was refused a licence for multiple sclerosis because of fears it increases the risk of cancer, but a new analysis finds no evidence to support this.…

Pembrolizumab endorsed as melanoma therapy by NICE

Pembrolizumab (Keytruda) has been recommended for use as a melanoma treatment in England by the National Institute for Health and Care Excellence.…

More drugs qualifying for FDA accelerated review, driven by non-innovative medicines

Over the past 30 years, more drugs qualified for accelerated approval programmes with the FDA despite not being first-in-class medicines.…

Developing new psoriasis treatment regimens for patients based on their clinical profile

Biologics and small-molecule drugs being developed to treat psoriasis are showing encouraging results, but high costs could limit their use.…