Blog
RSS FeedPosted by Michael Wonder on 01 Jun 2016
U.S. FDA approves once-daily Jentadueto XR (linagliptin and metformin hydrochloride extended release tablets) for adults with type 2 diabetes
31 May 2016 - The US FDA has approved Jentadueto XR (linagliptin and metformin hydrochloride extended release tablets) for the treatment ...
Posted by Michael Wonder on 31 May 2016
Allergan receives FDA approval of Teflaro (ceftaroline fosamil acetate monohydrate) for paediatric patients
31 May 2016 - Teflaro is the first branded IV antibiotic approved for paediatric patients in more than a decade. ...
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 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
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
FDA approval of Afstyla (rFVIII-single chain)
26 May 2016 - CSL today announced that the US FDA has approved Afstyla [anti-haemophilic factor (recombinant), single chain], CSL Behring’s ...
Posted by Michael Wonder on 25 May 2016
FDA expands indication of Invokamet (canagliflozin/metformin HCl) to include first-line treatment of adults with type 2 diabetes
24 May 2016 - Janssen Pharmaceuticals today announced the U.S. FDA has approved Invokamet, a fixed-dose combination therapy of Invokana (canagliflozin) ...
Posted by Michael Wonder on 24 May 2016
FDA approves CSL's Flucelvax quadrivalent influenza vaccine
24 May 2016 - CSL today announced that the US FDA has approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the first four-strain, ...
Posted by Michael Wonder on 24 May 2016
Patient reported outcomes labeling for products approved by the Office of Hematology and Oncology Products of the US FDA (2010-2014)
23 May 2016 - Ari Gnanasakathy et al. have reviewed the use of patient-reported outcome (PRO) data in medical product labeling ...
Posted by Michael Wonder on 24 May 2016
Samsung targets US drug market with Remicade knockoff
24 May 2016 - Affiliate Samsung Bioepis says its biosimilar of the arthritis drug is being reviewed by the FDA. ...