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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces acceptance of new drug application for investigational daclatasvir for FDA review for the treatment of hepatitis C genotype 3
Bristol-Myers Squibb Company announced today that the resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, has ...
Posted by Michael Wonder on 05 Aug 2015
FDA files supplemental new drug application for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis and pulmonary embolism after hip replacement surgery
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) filed a supplemental New Drug Application ...
Posted by Michael Wonder on 05 Aug 2015
Progenics announces breakthrough therapy designation for Azedra in pheochromocytoma and paraganglioma
Progenics Pharmaceuticals, Inc., an oncology company developing innovative ways to target and treat cancer, announced today that the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
Merck KGaA, Threshold win fast track for pancreatic cancer drug
Germany's Merck KGaA said that experimental cancer drug evofosfamide, which it is jointly developing with Threshold Pharmaceuticals, won fast track ...
Posted by Michael Wonder on 05 Aug 2015
AbbVie announces U.S. FDA approval of Duopa (carbidopa and levodopa) enteral suspension for the treatment fo motor fluctuations in patients with advanced Parkinson's disease
The U.S. Food and Drug Administration (FDA) has approved AbbVie's Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small ...
Posted by Michael Wonder on 05 Aug 2015
Amarin provides update on ANCHOR trial SPA agreement rescission appeal
Amarin Corporation plc, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today ...
Posted by Michael Wonder on 05 Aug 2015
Hospira receives U.S. FDA approval of proprietary analgesic Dyloject (diclofenac sodium) injection
Hospira, Inc, the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received ...
Posted by Michael Wonder on 05 Aug 2015
Merck submits U.S. new drug application for grazoprevir/elbasvir, an investigational once-daily, single tablet combination therapy, for treatment of chronic hepatitis C genotypes 1, 4, and 6 infection
Merck, known as MSD outside the United States and Canada, today announced that the company has submitted a New Drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new product to treat rare genetic disease
The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute ...
Posted 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 ...