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RSS FeedPosted 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 ...
Posted by Michael Wonder on 17 Sep 2015
FDA approves new indication for Spiriva Respimat
16 September 2015 - Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Spiriva Respimat (tiotropium bromide ...
Posted by Michael Wonder on 16 Sep 2015
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. Food and Drug Administration for advanced renal cell carcinoma
16 September 2015 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy ...
Posted by Michael Wonder on 16 Sep 2015
FDA approves Octapharma’s Nuwiq for the treatment of adults and children with haemophilia A
15 September 2015 - Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Nuwiq, anti-haemophilic factor (recombinant), ...
Posted by Michael Wonder on 15 Sep 2015
AbbVie announces submission of a supplemental new drug application for Imbruvica (Ibrutinib) for treatment-naive chronic lymphocytic leukaemia
14 September 2015 - AbbVie, a global biopharmaceutical company, announced today that it submitted a supplemental New Drug Application (sNDA) to ...