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RSS FeedPosted by Michael Wonder on 31 May 2016
European Commission approves Imbruvica (ibrutinib) for first-line treatment of patients with chronic lymphocytic leukaemia
31 May 2016 - Imbruvica is now indicated across all lines of chronic lymphocytic leukaemia in the European Union. ...
Posted by Michael Wonder on 31 May 2016
Amicus Therapeutics announces European Commission for Galafold (migalastat) in patients with Fabry disease in European Union
31 May 2016 - Galafold is the first precision medicine approved for Fabry disease. ...
Posted by Michael Wonder on 31 May 2016
Roche’s subcutaneous formulation of MabThera receives approval in Europe for people with chronic lymphocytic leukaemia
31 May 2016 - The subcutaneous formulation of MabThera saves time and eases treatment burden compared with the intravenous form. ...
Posted by Michael Wonder on 29 May 2016
FDA grants accelerated approval to Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cirrhosis
27 May 2016 - Ocaliva is the first new medicine for primary biliary cirrhosis in nearly 20 years. ...
Posted by Michael Wonder on 29 May 2016
Strimvelis receives European marketing authorisation to treat very rare disease, ADA-SCID
27 May 2016 - GSK, Fondazione Telethon and Ospedale San Raffaele gain approval to provide life-saving gene therapy to patients. ...
Posted by Michael Wonder on 28 May 2016
FDA approves Zinbryta to treat multiple sclerosis
27 May 2016 - The U.S. FDA today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple ...
Posted by Michael Wonder on 28 May 2016
AstraZeneca receives complete response letter from US FDA for sodium zirconium cyclosilicate (ZS-9) for oral suspension for treatment of hyperkalaemia
27 May 2016 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new drug ...
Posted by Michael Wonder on 28 May 2016
FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
27 May 2016 - The U.S. FDA today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron ...
Posted by Michael Wonder on 27 May 2016
Highlights from the CHMP 23-26 May 2016 meeting
27 May 2016 - Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval. ...
Posted by Michael Wonder on 27 May 2016
Two new combination therapies against chronic hepatitis C
27 May 2016 - Direct-acting antivirals Epclusa and Zepatier recommended for approval. ...
Posted by Michael Wonder on 27 May 2016
Vanda announces FDA approval of the Fanapt (iloperidone) supplemental new drug application for maintenance treatment of schizophrenia in adults
26 May 2016 - Vanda Pharmaceuticals today announced that the US FDA has approved Vanda's supplemental new drug application (sNDA) for ...
Posted by Michael Wonder on 27 May 2016
Cancer drugs are the least likely to receive FDA approval
26 May 2016 - But there’s good reason to hope that may change very soon. ...
Posted by Michael Wonder on 27 May 2016
Muscular dystrophy day at the FDA
25 May 2016 - The agency again delays a decision on a therapy for a deadly disease. ...
Posted by Michael Wonder on 26 May 2016
FDA approves first buprenorphine implant for treatment of opioid dependence
26 May 2016 - Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid ...
Posted by Michael Wonder on 26 May 2016
NICE issues draft guidance for necitumumab (Portrazza)
26 May 2016 - NICE has released an appraisal consulation document for necitumumab for untreated advanced or metastatic, squamous non-small-cell ...