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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Acorda Therapeutics announces notification of ANDA filing for Ampyra
Acorda Therapeutics, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Actavis Laboratories FL, Inc. submitted ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration accepts supplemental biologics license application for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental ...
Posted by Michael Wonder on 05 Aug 2015
GW Pharmaceuticals announces Epidiolex receives fast track designation from FDA for the treatment of Dravet syndrome
GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, ...
Posted by Michael Wonder on 05 Aug 2015
Celldex's rindopepimut (Rintega) receives FDA breakthrough therapy designation for the treatment of adult patients with EGFRvIII-positive glioblastoma
Celldex Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega) Breakthrough Therapy Designation for the treatment ...
Posted 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 ...