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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Celltrion files for US FDA approval of Remsima
Remsima is expected to be the first biosimilar monoclonal antibody to be filed through United States of America Food and Drug ...
Posted by Michael Wonder on 05 Aug 2015
AMAG Pharmaceuticals receives complete response letter from FDA for the single-dose vial of Makena (hydroxyprogesterone caproate injection)
AMAG Pharmaceuticals, Inc., today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding ...
Posted by Michael Wonder on 05 Aug 2015
Baxter submits application for U.S. FDA approval of BAX 855, extended half-life recombinant FVIII based on ADVATE for hemophilia A
Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first combination pill to treat hepatitis C
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype ...
Posted by Michael Wonder on 05 Aug 2015
MerLion announces FDA approval of finafloxacin otic suspension
MerLion Pharmaceuticals (MerLion), a biopharmaceutical company headquartered in Singapore with clinical development operations in Berlin, Germany, today announced that an otic suspension ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi and Regeneron announce Praluent (alirocumab) biologics license application has been accepted for priority review by US FDA
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review ...
Posted 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 ...