Approvals

Alert Carpuject Hydromorphone Prefilled Syringes Recalled The FDA is reporting a recall of one lot of Hospira hydromorphone injection for use with Carpuject cartridges.
News, August 16, 2012
Alert Immune Globulin Approved for Multifocal Motor Neuropathy Immune globulin infusion has been approved by the US Food and Drug Administration (FDA) as a treatment for multifocal motor neuropathy (MMN).
News, June 27, 2012
Alert Pertuzumab Approved for HER2 Breast Cancer This new product targets HER2-positive breast cancer, which accounts for about a quarter of all breast cancers, and works in synergy with trastuzumab.
News, June 11, 2012
First Cord-Blood Transplant Therapy Approved by FDA The new product, Hemacord, contains stem cells taken from the umbilical cord and placenta after childbirth that morph into various kinds of blood cells.
News, November 10, 2011
Alert FDA Recalls Mizuho Surgical Tables A class I recall has been issued on Mizuho surgical tables because of reports of patient injury.
News, November 10, 2011
FDA Approves Cetuximab for Metastatic Head and Neck Cancer The US Food and Drug Administration (FDA) has just added a new indication for cetuximab -- it can be combined with chemotherapy in the treatment of metastatic head and neck cancer.
News, November 07, 2011
Alert TNF Blockers and Cancer: FDA Requires Increased Surveillance The US Food and Drug Administration is requiring more stringent safety surveillance of TNF-blocker-related malignancy cases in children and young adults.
News, November 03, 2011
Aneurysm Stent Okayed for Patients With Small Arteries The stent for abdominal aortic aneurysms, which uses a delivery catheter narrower than any on the market, gives patients with small arteries the option of less invasive surgery.
News, November 02, 2011
FDA Okays Exparel for Postoperative Pain The FDA has approved Pacira Pharmaceuticals' nonopioid bupivacaine extended-release liposome injection.
News, October 31, 2011
Europe Okays Pneumonia Vaccine for Adults 50 Years and Older Pfizer's Prevenar 13 is the first and only pneumococcal conjugate vaccine approved for use in adults in the European Union.
News, October 28, 2011
Pemetrexed Approved in EU for NCSLC Continuation Maintenance This is the first chemotherapy approved in the European Union (EU) for continuation maintenance therapy in advanced nonsquamous nonsmall-cell lung cancer (NSCLC).
News, October 28, 2011
European Nod for HG Nerve Stimulation in Sleep Apnea Implantable device for hypoglossal nerve stimulation improves sleep apnea and quality of sleep, life, and health.
News, October 27, 2011
Alert FDA Provides Update on Drospirenone VTE Risk Further analysis of an FDA-funded study provides more evidence that drospirenone-containing oral contraceptives increase risk for venous thromboembolism, the agency says.
News, October 27, 2011
Alert Sepsis Drug Xigris Pulled From Worldwide Market Physicians should stop ongoing treatment with the drug now that it has failed a new efficacy test, according to the FDA.
News, October 25, 2011
Alert FDA Update for Neuropsychiatric Events With Varenicline The FDA says there is no difference in serious adverse events between the smoking cessation therapies varenicline and nicotine replacement therapy. However, questions and concerns linger.
News, October 24, 2011
Alert Do Not Give Flu Vaccine by Jet Injection, FDA Says Although several jet-injection devices are approved for delivering vaccines and other medications, no influenza vaccine has been cleared for this method of administration.
News, October 24, 2011
FDA Approves First Generic Versions of Olanzapine The FDA has approved the first generic versions of olanzapine for the treatment of schizophrenia and bipolar disorder.
News, October 24, 2011
FDA Approves Clobazam Add-On for Lennox Syndrome The benzodiazepine is already available in 100 other countries, marketed under different brand names.
News, October 24, 2011
FDA Okays Exenatide as Adjunct to Insulin Glargine The FDA has approved exenatide for patients with type 2 diabetes receiving the basal insulin analogue whether or not they also are receiving metformin alone or in combination with a thiazolidinedione.
News, October 24, 2011
Alert Protelos and Osseor Under Review by EMA The European Medicines Agency is now reviewing all relevant data on cardiovascular and cutaneous safety concerns for Protelos and Osseor.
News, October 21, 2011

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