FDA approves venetoclax for chronic lymphocytic leukaemia The US Food and Drug Administration has approved venetoclax for the treatment of chronic lymphocytic leukaemia.…
Enthusiasm for PCSK9 inhibitors to lower LDL cholesterol is premature Although PCSK9 inhibitors have been hailed as the next big thing in the treatment of high cholesterol, there are not enough data to make informed opinions about their overall value.…
How to set up corrective and preventative action programmes in pharma ‘CAPA in the pharmaceutical and biotech industries: how to implement an effective nine step program’ by Jackelyn Rodriguez.…
FDA approves first treatment for stem cell transplant patients who develop rare liver condition The US Food and Drug Administration has approved a new treatment for hepatic veno-occlusive disease, a rare and life threatening liver condition that can develop in cancer patients who undergo hematopoietic stem cell transplantation.…
Teva’s injectable asthma biologic approved by FDA The US Food and Drug Administration has approved Teva Pharmaceutical Industries’ humanised monoclonal antibody reslizumab (Cinqair) as a treatment for severe asthma.…
FDA approves injectable psoriasis drug The US Food and Drug Administration has approved an injectable treatment, ixekizumab (Taltz; Eli Lilly), for adults with moderate to severe plaque psoriasis. …
FDA approves anthrax treatment The US medicines safety watchdog has approved obiltoxaximab (Anthim) for the treatment of inhalational anthrax in combination with other therapies and when other treatments are either unavailable or inappropriate.…
Sex bias in drug research: a call for change Because medical and drug research is conducted mainly on men, there can be dangerous consequences for women who receive the same treatment.…
FDA approves coagulation factor-albumin fusion protein to treat haemophilia B Idelvion, a coagulation factor-albumin fusion protein product for use in children and adults with haemophilia B, has been approved by the US Food and Drug Administration.…
New FDA commissioner appointed Robert Califf has been confirmed as the new commissioner of the US Food and Drug Administration (FDA). …
