Blog
RSS FeedPosted by Michael Wonder on 02 Sep 2015
Costly hepatitis C drugs for everyone?
1 September 2015 - New drugs to treat hepatitis C are tremendously effective — and tremendously costly — raising fears that ...
Posted by Michael Wonder on 01 Sep 2015
Telesta receives FDA BLA filing notification letter and priority review designation for MCNA
28 August 2015 - Telesta Therapeutics Inc. announced today that it has received its BLA Filing Notification for MCNA from the ...
Posted by Michael Wonder on 01 Sep 2015
U.S. Food and Drug Administration accepts for priority review the biologics license application for Empliciti (elotuzumab) for the treatment of multiple myeloma in patients who have received one or more prior therapies
1 September 2015 - Bristol-Myers Squibb Company and AbbVie today announced the U.S. Food and Drug Administration (FDA) has accepted for ...
Posted by Michael Wonder on 31 Aug 2015
Titan Pharmaceuticals announces resubmission of the new drug application for Probuphine for the maintenance treatment of opioid addiction
31 August 2015 - Titan Pharmaceuticals, Inc, a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases ...
Posted by Michael Wonder on 31 Aug 2015
FDA grants priority review for Intercept's obeticholic acid for the treatment of primary biliary cirrhosis
31 August 2015 - Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development and commercialisation of novel therapeutics ...
Posted by Michael Wonder on 30 Aug 2015
Sunovion announces FDA approval of a new indication for Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures
28 August 2015 - Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental ...
Posted by Michael Wonder on 30 Aug 2015
FDA approves Amgen's cholesterol-lowering drug Repatha
27 August 2015 - The U.S. Food and Drug Administration on Thursday approved Amgen Inc's Repatha drug for patients with ...
Posted by Michael Wonder on 30 Aug 2015
New alternatives to statins add to a quandary on cholesterol
30 August 2015 - Doctors have long faced a conundrum in prescribing statins to lower cholesterol and heart attack risk: The ...
Posted by Michael Wonder on 27 Aug 2015
FDA approves Amgen's new cholesterol-lowering medication Repatha (evolocumab)
27 August 2015 - Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved a new cholesterol-lowering ...
Posted by Michael Wonder on 27 Aug 2015
Unapproved Lilly lung cancer drug stirs price debate
27 August 2015 - An experimental Eli Lilly & Co. lung cancer drug hasn’t reached the market, but some doctors ...
Posted by Michael Wonder on 27 Aug 2015
U.S. FDA approves Synjardy (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes mellitus
27 August 2015 - The U.S. Food and Drug Administration (FDA) has approved Synjardy (empagliflozin with metformin hydrochloride) tablets, from Boehringer ...
Posted by Michael Wonder on 27 Aug 2015
FDA approves Repatha to treat certain patients with high cholesterol
27 August 2015 - The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable ...
Posted by Michael Wonder on 27 Aug 2015
Nonproprietary naming of biological products
27 August 2015 - The FDA has issued draft guidance on the non-proprietary naming of biological products. ...
Posted by Michael Wonder on 26 Aug 2015
FDA issues draft guidance on common issues in drug development for rare diseases
17 August 2015 - The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Rare ...
Posted by Michael Wonder on 26 Aug 2015
FDA grants priority review to Sarepta drug candidate
25 August 2015 - U.S. health regulators granted priority review status for Sarepta Therapeutics Inc.’s treatment of a rare genetic disorder. ...