US Food and Drug Administration (FDA)

FDA to propose cut in nicotine levels in cigarettes

The US Food and Drug Administration has announced a new plan for tobacco and nicotine regulation, which could result in nicotine levels in cigarettes being lowered…

‘Living drug’ may soon be approved by the FDA for treatment of acute lymphoblastic leukaemia

CAR-T cell immunotherapy recommended for approval and may get FDA go ahead by the end of 2017.…

FDA approves drug to reduce risk of HER2-positive breast cancer returning

The US Food and Drug Administration (FDA) has approved neratinib (Nerlynx; Puma Biotechnology) as the first extended adjuvant therapy for early-stage, HER2-positive breast cancer.…

Psoriasis drug approved by FDA

The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis…

US pharmacists to get opioid addiction training

US drug regulators have called for pharmacists to have access to training on appropriate prescribing of opioid medicines to help tackle addiction.…

Lack of robust post-approval studies under FDA system

Review of drugs approved on the basis of limited evidence concludes that stricter rules are needed for post-approval studies.…

First cancer treatment for solid tumour with specific genetic feature approved in US

The US Food and Drug Administration has approved the first cancer treatment for use against tumours with a common biomarker regardless of where in the body the tumour originated.…

Pain patients treated with ketamine less likely to experience depression

Large-scale data from the US Food and Drug Administration suggest that ketamine should be studied for use in patients suffering from depression.…

FDA approves first treatment for giant cell arteritis

Subcutaneous tocilizumab (marketed as Actemra) has been approved by the US drug safety watchdog to treat adults with giant cell arteritis, a type of vasculitis.…

FDA issues amputation warning for diabetes drug canagliflozin

The drug regulator in the United States has issued a warning on diabetes drug canagliflozin after two large clinical trials found that it was associated with an increased risk of leg and foot amputations.…