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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Bayer submits application for U.S. FDA approval for recombinant factor VIII product (BAY 81-8973) for the treatment of Hemophilia A in adults and children
Bayer HealthCare today announced that it has filed a Biologics License Application (BLA) to the U.S. Food and Drug Administration ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants priority review to Boehringer Ingelheim’s biologics license application for idarucizumab
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the ...
Posted by Michael Wonder on 05 Aug 2015
Clovis Oncology receives breakthrough therapy designation for CO-1686 for the second-line treatment of EGFR mutant non small-cell lung cancer in patients with the T790M mutation
Clovis Oncology announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent CO-1686 ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA grants priority review to lifitegrast NDA for the treatment of dry eye disease in adults
Shire plc. today announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application ...
Posted by Michael Wonder on 05 Aug 2015
This cancer doctor is leading the attack on astronomical drug prices
As the one-year cost of cancer drugs edges up to $200,000 per patient, a top doctor from Memorial Sloan Kettering Cancer Center used his ...
Posted by Michael Wonder on 05 Aug 2015
BI's nintedanib gets FDA breakthrough status for IPF
Boehringer Ingelheim’s nintedanib has been awarded breakthrough therapy designation by the US Food and Drug Administration as a treatment for ...
Posted by Michael Wonder on 05 Aug 2015
Shire’s investigational SHP609, idursulfase-IT, receives FDA Fast Track designation for the treatment of neurocognitive decline associated with Hunter syndrome
Shire plc announces that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP609 (idursulfase-IT; also ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands uses of Vyvanse to treat binge-eating disorder
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves a new ultrasound imaging agent
The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives complete response letter from U.S. Food and Drug Administration for daclatasvir, an investigational treatment for hepatitis C
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding ...
Posted by Michael Wonder on 05 Aug 2015
Gilead submits new drug application to U.S. Food and Drug Administration for fixed-dose combination of emtricitabine/tenofovir alafenamide for HIV treatment
Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces plans for third quarter submission of a biologics license application for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, for previously treated advanced melanoma
Bristol-Myers Squibb Company today announced that, following discussions with the U.S. Food and Drug Administration (FDA), the company is planning a ...
Posted by Michael Wonder on 05 Aug 2015
Alexion completes rolling BLA submission to U.S. FDA for asfotase alfa as a treatment for patients with pypophosphatasia
Alexion Pharmaceuticals, Inc. announced today completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA has granted priority review for Olysio in combination with sofosbuvir supplementary New Drug Application
Medivir AB announces that the Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Lenvima for a type of thyroid cancer
The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer ...