Approvals

Alert FDA Approves SGLT2 Inhibitor Ertugliflozin for Type 2 Diabetes The US Food and Drug Administration has approved ertugliflozin, a fourth SGLT2 inhibitor for use in adults with type 2 diabetes .
News, December 21, 2017
FDA Warns About Amputation Risk With Canagliflozin UPDATED // The agency is investigating whether the twofold increase in amputations seen in an ongoing trial is attributable to the drug.
News, May 18, 2016
New Continuous Glucose Monitor Software Improves Accuracy The US Food and Drug Administration (FDA) has approved new software for the Dexcom G4 Platinum system that the company says brings its accuracy close to that of finger-stick testing.
News, November 12, 2014
Alert Trametinib (Mekinist) Now Approved in EU for Melanoma The first MEK-inhibitor is now approved, specifically for use as a single agent in adults with unresectable or metastatic melanoma and BRAF mutations.
News, July 04, 2014
Alert FDA Rejects Novo Nordisk's Insulin Degludec The FDA has told Novo Nordisk that it wants more cardiovascular outcomes data on its long-acting basal insulin degludec; the company says it will not be able to provide the information this year.
News, February 11, 2013
Alert FDA Approves Higher Dose of Hydromorphone The FDA has approved a 32-mg tablet strength of hydromorphone HCI extended-release tablets (Exalgo, Mallinckrodt) for moderate to severe chronic pain.
News, August 29, 2012
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

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