Narcan nasal application receives FDA approval
The U.S. Food and Drug Administration has given approval for the use of Narcan, an emergency treatment medication to counteract heroin overdoses, in a nasal spray form. Read More »
The U.S. Food and Drug Administration has given approval for the use of Narcan, an emergency treatment medication to counteract heroin overdoses, in a nasal spray form. Read More »
A new drug formulary that will allow cancer centers to access approved and investigational drugs for the use of preclinical and clinical studies in cancer treatment has been launched by the National Cancer Institute. Read More »
New consensus recommendations from the Academy of Managed Care Pharmacy ask the U.S. Food and Drug Administration to allow biopharmaceutical companies to share patient health and economic information with policy makers. Read More »
The FDA has extended the review period for Baricitnib, a new once-a-day drug for rheumatoid arthritis. Read More »
The U.S. Food and Drug Administration has approved Vantrelatm, a pain medication designed by Teva Pharmaceutical Ltd., for long-term use in time-released capsules. Read More »
The European Commission has granted Gilead Sciences Inc. marketing authorization for Vemlidy, a drug used in the treatment of people suffering from chronic Hepatitis B infections. Read More »
The U.S. Food and Drug Administration recently approved a license application for Mylan Biotechnology, in collaboration with Biocon, for the use of biosimilar tratuzumab in the treatment of breast cancer. Read More »
Ovarian cancer patients who have a sensitivity to chemotherapy will soon have another option to treat their disease as the U.S. Food and Drug Administration has approved Avastin as an alternative to or supplement for chemotherapy. Read More »
Biotech group Genentech scored a big victory as the U.S. Food and Drug Administration has granted a priority review of the company’s newest cancer-treating drug, Tecentriq. Read More »
The U.S. Food and Drug Administration has approved the use of Lucentis, created by biotech company Genentech, for people suffering with severe nearsightedness. Read More »
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 »