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Amgen submits biologics license application for fda approval of denosumab in women with postmenopausal osteoporosis and in patients undergoing hormone ablation for either prostate or breast cancer THOUSAND OAKS, Calif., Dec. 19 (HSMN NewsFeed) -- Amgen Inc. (Nasdaq: AMGN ), today announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for denosumab, an investigational RANK Ligand inhibitor. Th... BiopharmaceuticalsAmgen, denosumab, osteoporosis, RANK Ligand (Source: HSMN NewsFeed) Med WormFDA approves Mozobil (plerixafor) for multiple myeloma or non-Hodgkin`s lymphomas The U.S. Food and Drug Administration has approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. news-medical.netNeuralstem files IND for amyotrophic lateral sclerosis stem cell trial Neuralstem, Inc. announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). news-medical.netFreshDirect At The Office Introduces `Smart Eating At Office` FreshDirect At The Office, the corporate arm of the leading online fresh food purveyor and delivery service, today announced its collaboration with IAC (Nasdaq: IACI), a leading internet company with more than 35 consumer brands across 40 countries, to launch 'Smart Eating at the Office,' a new eating program designed to promote better nutrition and introduce healthy eating options to the workplace.read more E max healthFDA Approves Drug Boosting Stem Cell Yield For Bone Marrow Transplants The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.read more TelegrapheMedical Mystery: Fainting by Sandwich? An unusual condition causes U.K. woman to pass out while eating certain foods. ABC NewsAnti-smoking bill dies in Lansing today LANSING -- State lawmakers this morning abandoned, for this year, efforts to ban smoking in all workplaces, including bars, restaurants and casinos. As the hours ticked down on what likely is their fi... Jointogether.orgLETTER: ZELLER: The F.D.A. and Smoking Martin Lindstrom alleges that a 'key component of the Food and Drug Administration's approach to smoking prevention is to warn about health dangers.'The Bush administration has had absolutely no commitment to smoking prevention, and actively opposed legislation to restore regulatory authority over tobacco products to the F.D.A. There was neither an F.D.A. 'approach' nor any 'components.'The proposed legislation to put the F.D.A. in the business of regulating tobacco products is comprehensive. It addresses every element of tobacco control, from preventing youth from taking up smoking to encouraging the F.D.A. to do all that it can to help more addicted adult smokers quit.The public health community looks forward to the day when, in an enlightened administration, the F.D.A. is actually doing something about the marketing of tobacco products that are deliberately designed by their manufacturers to addict and shorten the lives of their customers. Tobacco.orgFDA Announces New Recommendations On Evaluating Cardiovascular Risk In Drugs Intended To Treat Type 2 Diabetes The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development. 'We need to better understand the safety of new antidiabetic drugs. Medicalnewstoday.comAbbott Receives FDA Approval For TRILIPIXT, First And Only Fibrate Indicated For Use In Combination With A Statin For Cholesterol Management Recently, the U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIXT (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. Medicalnewstoday.com1 2 |
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