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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Actavis and Medicines360 announce FDA approval of Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to three years
Actavis plc, a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval ...
Posted by Michael Wonder on 05 Aug 2015
Genzyme's Lemtrada resubmission accepted for review by FDA
Genzyme, a Sanofi company , announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission ...
Posted by Michael Wonder on 05 Aug 2015
Zogenix receives FDA approval of new formulation of Zohydro ER
30 January 2015 - Zogenix, Inc., a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts supplemental new drug application for priority review of Rapamune (sirolimus) for treatment of lymphangioleiomyomatosis
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer Announces FDA acceptance for review of supplemental new drug application for oral Xeljanz (tofacitinib citrate) for adult patients with moderate to severe chronic plaque psoriasis
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Lynparza to treat advanced ovarian cancer
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new psoriasis drug Cosentyx
The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis. ...
Posted by Michael Wonder on 05 Aug 2015
The Medicines Company announces FDA approval of Kengreal (cangrelor) as an adjunct to percutaneous coronary intervention for reducing thrombotic events
The Medicines Company today announced the approval of Kengreal (cangrelor) by the U.S. Food and Drug Administration (FDA) as an adjunctive therapy to percutaneous coronary intervention ...
Posted by Michael Wonder on 05 Aug 2015
Impax Pharmaceuticals announce FDA approval of Rytary (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson's disease
Impax Pharmaceuticals, a division of Impax Laboratories, Inc, today announced that the U.S. Food and Drug Administration (FDA) approved Rytary, an extended-release oral ...
Posted by Michael Wonder on 05 Aug 2015
Court blocks Novartis copy of Amgen cancer-care drug
A U.S. appeals court has blocked Novartis AG from selling its knockoff version of an Amgen Inc. cancer supportive-care drug in the U.S. until the court ...
Posted by Michael Wonder on 05 Aug 2015
Alkermes submits new drug application to FDA for aripiprazole lauroxil for treatment of schizophrenia
Alkermes plc today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval ...
Posted by Michael Wonder on 05 Aug 2015
Actavis and Adamas announce FDA approval of Namzaric, a fixed-dose combination of memantine hydrochloride extended-release and donepezil hydrochloride
Actavis plc and Adamas Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, ...
Posted by Michael Wonder on 05 Aug 2015
AbbVie's Humira (adalimumab) receives U.S. FDA approval for extension of polyarticular juvenile idiopathic arthritis indication to patients ages 2 years and older
AbbVie today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the Humira indication for moderately to severely ...
Posted by Michael Wonder on 05 Aug 2015
Iroko Pharmaceuticals announces acceptance of U.S. filing for SoluMatrix meloxicam in osteoarthritis pain
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that the U.S. ...
Posted by Michael Wonder on 05 Aug 2015
FDA Fast Track Designation granted to luspatercept for the treatment of patients with beta-thalassemia
Celgene Corporation and Acceleron Pharma Inc. today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designations ...