FDA approves first app for substance abuse disorders The US Food and Drug Administration has approved a mobile app for therapeutic purposes for the first time.…
FDA approves AML drug 17 years after initial approval The Food and Drug Administration has approved the use of gemtuzumab (Mylotarg) for the treatment of adults with acute myeloid leukaemia whose tumours express the CD33 antigen.…
FDA approves cancer therapy using genetically engineered cells The US Food and Drug Administration has approved the first gene therapy, which will be available to children and adults with acute lymphoblastic leukaemia.…
FDA and EMA sign confidentiality commitment Medicine inspectors in the European Union will be given access to secret and commercially sensitive information by the Food and Drug Administration (FDA) in the US, after signing a new confidentiality commitment.…
FDA to examine opioid-containing cough medicine for children The US drug safety watchdog is convening a panel of experts to consider the risks and benefits of opioid-containing prescription cough medicine for children.…
Quality of FDA fast-track approvals evidence questioned by research Research suggests that the US medicines agency has approved indications for many drugs in response to data from less rigorous trials, despite the randomised controlled trial being the ‘gold standard for approval’.…
Director of RPS in Scotland calls for e-cigarette evidence review The director of the Royal Pharmaceutical Society in Scotland, Alex MacKinnon, has called for a review of the evidence on e-cigarettes.…
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.…
