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RSS FeedPosted by Michael Wonder on 22 Oct 2015
FDA approves new drug to treat patients with hyperkalaemia
21 October 2015 - The U.S. Food and Drug Administration today approved Veltassa (patiromer) to treat patients with hyperkalaemia. ...
Posted by Michael Wonder on 20 Oct 2015
FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder
20 October 2015 - The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X ...
Posted by Michael Wonder on 16 Oct 2015
FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa
16 October 2015 - The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients ...
Posted by Michael Wonder on 09 Oct 2015
FDA expands approved use of Opdivo in advanced lung cancer
9 October 2015 - The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small ...
Posted by Michael Wonder on 08 Oct 2015
Merck KGaA and Pfizer announce investigational immunotherapy avelumab receives FDA fast track designation for metastatic Merkel cell carcinoma
7 October 2015 - Merck KGaA and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab, ...
Posted by Michael Wonder on 06 Oct 2015
FDA approves new injectable drug to treat schizophrenia
7 October 2015 - On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to ...
Posted by Michael Wonder on 06 Oct 2015
U.S. FDA grants priority review for Daklinza (daclatasvir) sNDAs
6 October 2015 - Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing ...
Posted by Michael Wonder on 03 Oct 2015
FDA approves Keytruda for advanced non-small cell lung cancer
3 October 2015 - The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with ...
Posted by Michael Wonder on 02 Oct 2015
FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept
2 October 2015 - Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and ...
Posted by Michael Wonder on 25 Sep 2015
FDA approves two new drug treatments for diabetes mellitus
25 September 2015 - The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin ...
Posted by Michael Wonder on 25 Sep 2015
Will the FDA approve all 3 of these cancer drugs in October?
25 September 2015 - The World Health Organization identified more than 14,000 disease, disorders, and ailments in 2011, but none continues ...
Posted by Michael Wonder on 22 Sep 2015
FDA approves new oral medication to treat patients with advanced colorectal cancer
22 September 2015 - The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and ...
Posted by Michael Wonder on 21 Sep 2015
FDA awards 18 grants to stimulate product development for rare diseases
21 September 2015 - The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more ...
Posted by Michael Wonder on 20 Sep 2015
F.D.A. nominee Califf’s ties to drug makers worry some
20 September 2015 - At a DoubleTree Hotel in Durham, N.C., in May 2014, Dr. Robert M. Califf gave a presentation ...
Posted by Michael Wonder on 18 Sep 2015
FDA approves new drug to treat schizophrenia and bipolar disorder
17 September 2015 - The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder ...