Obeticholic acid gets US approval for rare liver disease The US Food and Drug Administration has approved a new drug called Ocaliva (obeticholic acid) for patients with primary biliary cholangitis. …
US FDA approves first PD-1/PD-L1 inhibitor for most common bladder cancer The US Food and Drug Administration has approved the immunotherapy atezolizumab (Tecentriq) to treat urothelial carcinoma, the most common form of bladder cancer.…
FDA approves pimavanserin to treat hallucinations and delusions in Parkinson’s disease A drug to treat hallucinations and delusions in patients with Parkinson’s disease is being made available in the United States.…
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.…