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RSS FeedPosted 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 ...
Posted by Michael Wonder on 15 Sep 2015
Erytech submits EMA marketing authorisation application for Graspa to treat acute lymphoblastic leukaemia
14 September 2015 - Erytech Pharma, the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other ...
Posted by Michael Wonder on 11 Sep 2015
Amgen submits application to FDA for new delivery option for monthly administration of Repatha (evolocumab)
11 September 2015 - Amgen today announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking ...
Posted by Michael Wonder on 11 Sep 2015
AbbVie's Humira (adalimumab) receives U.S. FDA approval for moderate to severe hidradenitis suppurativa
10 September 2015 - AbbVie, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Humira ...
Posted by Michael Wonder on 10 Sep 2015
U.S. FDA accepts first digital medicine new drug application for Otsuka and Proteus Digital Health
10 September 2015 - Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health today announced that the United States Food and Drug ...
Posted by Michael Wonder on 10 Sep 2015
FDA grants fast track designation for MediciNova's MN-001 (tipelukast) for the treatment of idiopathic pulmonary fibrosis
10 September 2015 - MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the ...
Posted by Michael Wonder on 09 Sep 2015
U.S. FDA grants priority review to Takeda's ixazomib citrate for patients with relapsed/refractory multiple myeloma
9 September 2015 - Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has granted priority ...
Posted by Michael Wonder on 09 Sep 2015
FDA grants Genentech’s alectinib priority review for specific type of ALK-positive lung cancer
9 September 2015 - Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 04 Sep 2015
Alexion receives notification of PDUFA date extension for Kanuma (sebelipase alfa)
4 September 2015 - Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription ...