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RSS FeedPosted by Michael Wonder on 03 Sep 2015
U.S. FDA approves update of Simponi Aria (golimumab for infusion) label to include improvement in both physical and emotional measures of health when treating moderately to severely active rheumatoid arthritis
4 September 2015 - Janssen Biotech, Inc. announced today the approval of a U.S. Food and Drug Administration (FDA) Supplemental ...
Posted by Michael Wonder on 03 Sep 2015
Novartis launches first U.S. 'biosimilar' drug at 15 percent discount
3 September 2015 - Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first ...
Posted by Michael Wonder on 03 Sep 2015
Sandoz launches Zarxio (filgrastim-sndz), the first biosimilar in the United States
3 September 2015 - Sandoz, a Novartis company, announced today that Zarxio (filgrastim-sndz) is now available in the United States. Zarxio ...
Posted by Michael Wonder on 02 Sep 2015
Allergan announces FDA approval of updated label for Teflaro (ceftaroline fosamil)
2 September 2015 - Allergan plc. today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new ...
Posted by Michael Wonder on 02 Sep 2015
Tesaro announces U.S. FDA approval of Varubi (rolapitant) for nausea and vomiting associated with cancer chemotherapy
2 September 2015 - Tesaro, an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ...
Posted by Michael Wonder on 02 Sep 2015
U.S. Food and Drug Administration accepts supplemental biologics license application for Opdivo (nivolumab) in previously treated non-squamous non-small cell lung cancer patients
2 September 2015 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing ...
Posted by Michael Wonder on 02 Sep 2015
FDA approves new drug treatment for nausea and vomiting from chemotherapy
2 September 2015 - The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting ...
Posted 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 ...