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RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA grants priority review for three-month paliperidone palmitate for the treatment of schizophrenia
Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review ...
Posted by Michael Wonder on 05 Aug 2015
Company creates bioethics panel on trial drugs
Johnson & Johnson has appointed a nationally known bioethicist to create a panel that will make decisions about patients’ requests for ...
Posted by Michael Wonder on 05 Aug 2015
Grazoprevir/elbasvir, Merck’s investigational chronic hepatitis C therapy, granted FDA breakthrough therapy designations
Merck, known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves first-in-class Glyxambi (empagliflozin/linagliptin) tablets for adults with type 2 diabetes
The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company, as an ...
Posted by Michael Wonder on 05 Aug 2015
Salix announces FDA approval of Xifaxan 550 mg for the treatment of IBS-D (irritable bowel syndrome with diarrhoea)
Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves two therapies to treat IBS-D
The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different ...
Posted by Michael Wonder on 05 Aug 2015
Alcon receives FDA approval of Pazeo solution for ocular allergy itch relief
Alcon, the global leader in eye care and a division of Novartis, has received approval from the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb Statement about asunaprevir in the U.S.
Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new antibacterial drug Avycaz
The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy
The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Esbriet to treat idiopathic pulmonary fibrosis
The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). ...
Posted by Michael Wonder on 05 Aug 2015
InterMune announces resubmission of NDA for pirfenidone for the treatment of patients with IPF
InterMune, Inc. today announced that it has resubmitted its pirfenidone New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in ...
Posted by Michael Wonder on 05 Aug 2015
Runaway drug prices
A drug to treat abnormal heart rhythms can cost about $200 on one day and more than $1,300 the next. ...
Posted by Michael Wonder on 05 Aug 2015
Cyramza now approved in the U.S. for use with FOLFIRI in second-line treatment of metastatic colorectal cancer
5 November 2014 - Eli Lilly and Company has received its fourth U.S. FDA approval for Cyramza (ramucirumab). ...
Posted by Michael Wonder on 05 Aug 2015
Amgen submits supplemental new drug application for Kyprolis (carfilzomib) in relapsed multiple myeloma
Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Kyprolis (carfilzomib) ...