The U.S. Food and Drug Administration granted orphan drug designation to Alexion Pharmaceuticals for ALXN1210, a drug for treating patients with paroxysmal nocturnal hemoglobinuria. Read More »
The U.S. Food and Drug Administration granted orphan drug designation to Acucela's leading drug candidate emixustat hydrochloride, which was created to treat Stargardt disease. Read More »
AcelRX Pharmaceuticals recently submitted a new drug application to the U.S. Food and Drug Administration for ARX-04. Read More »
Marrk Merritt, president and CEO of the Pharmaceutical Care Management Association, writes, "The truth is PBMs reduce costs for payers and consumers by 30 percent or more and are part of the solution. It’s time for drug manufacturers to take responsibility for their own business mistakes instead of blaming others." Read More »
Endo International, PLC, a subsidiary of Par Pharmaceutical, recently released mycophenolate mofetil hydrochloride (HCI) in the U.S. following Food and Drug Administration approval of its Abbreviated New Drug Application. Read More »
Ablative Solutions' Investigational New Drug application for the Peregrine System Kit -- a catheter-based renal denervation that targets the delivery of alcohol to treat uncontrolled hypertension -- has been accepted by the U.S. Food and Drug Administration. Read More »
Argentina's regulatory body has approved Hemispherx Biopharma's New Drug Application for the commercial sale of rintatolimod. Read More »
Profounda's miltefosine has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. Read More »
Eli Lilly and Co., along with Incyte Corp., have announced that baricitinib received a positive opinion as well as a recommendation for approval from the European Medicines Agency Committee for Medicinal Products for Human Use. Read More »
AcelRx Pharmaceuticals has submitted a New Drug Application for ARX-04 (sufentanil sublingual tablet, 30 mcg) to the U.S. Food and Drug Administration. Read More »
Cognition Therapeutics has initiated testing of CT1812 in clinical trials in the United States. Read More »
Merck recently released KEYTRUDA data demonstrating an overall response rate of 41 percent in patients with relapsed or refractory primary mediastinal large B-cell lymphoma. Read More »
Theravance Biopharma's velusetrag (TD-5108) has been granted Fast Track designation by the U.S. Food and Drug Administration. Read More »
AbbVie's risankizumab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the investigational treatment of pediatric patients who have Crohn’s disease. Read More »
Otsuka Pharmaceuticals and Lundbeck's supplemental New Drug Application for the expanded labeling of ABILIFY MAINENA has been completed and will receive a substantive review by the U.S. Food and Drug Administration. Read More »
Biological Industries' Drug Master File for NutriStem hPSC XF Medium has been accepted by the U.S. Food and Drug Administration. Read More »
The U.S. Food and Drug Administration has approved Armodafinil Tablets developed by Lupin Pharmaceuticals. Read More »
Intarcia Therapeutics has submitted its New Drug Application (NDA) for ITCA 650 to the U.S. Food and Drug Administration. Read More »
AbbVie's oral poly polymerase inhibitor valiparib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. Read More »
Kedrion Biopharma and Kamada's Biologics License Application for human anti-rabies immunoglobulin therapy has been accepted for review by the U.S. Food and Drug Administration. Read More »
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