Approvals

Telaprevir Receives European Approval The hepatitis C drug, marketed under the brand name Incivek in the United States, will be sold as Incivo throughout the European Union.
News, September 21, 2011
Europe Approves Telavancin for Hospital-Acquired Pneumonia Clinical study data suggest telavancin's clinical efficacy is comparable to that of vancomycin.
News, September 19, 2011
FDA Approves Denosumab for Patients With Cancer The bone-modifying drug is now indicated to increase bone mass and reduce fracture risk in men and women undergoing hormone ablation therapy for cancer.
News, September 19, 2011
Alert Qualitest Oral Contraceptives Recalled A packaging error has prompted generic drugmaker Qualitest Pharmaceuticals to recall multiple lots of oral contraceptives.
News, September 16, 2011
Orphan Drug Status for Corneal Cross-Linking in Keratoconus Corneal cross-linking is the first medical therapy available in the US to slow disease progress.
News, September 14, 2011
Health Canada Approves Everolimus for Pediatric Brain Tumors Everolimus is for the treatment of tumors caused by tuberous sclerosis complex.
News, September 14, 2011
FDA Clears Brachytherapy System for Brain Cancer Dual balloon system delivers high-dose radiation to brain tumors.
News, September 14, 2011
Alert Class I Recall of Certain Medtronic Infusion Pumps Film formation in the pumps' batteries has been linked to reduced performance and loss of therapy.
News, September 13, 2011
Precision Laser System Approved for Cataract Surgery in Europe A new image guidance system automatically detects lens and corneal surfaces for safe and accurate laser delivery.
News, September 12, 2011
Abiraterone for Prostate Cancer Now Approved in Europe Experts welcome the new drug because men with castration-resistant prostate cancer that has progressed on chemotherapy have few options.
News, September 08, 2011
Neurostimulation Gets CE Mark Approval for Chronic Migraine European CE Mark approval has been granted for implanted neurostimulation system to treat intractable chronic migraines.
News, September 07, 2011
Alert DEA Moves to Make 'Bath Salts' Illegal as Overdoses Rise The abuse of psychoactive 'bath salts' has become commonplace, and patients with PABS overdoses are presenting to emergency departments with increasing frequency.
News, September 07, 2011
Alert TNF Blockers Get Boxed Warning on 2 Bacterial Infections A recent FDA review of the drug class, prescribed for various forms of arthritis and other disorders, uncovered serious and sometimes fatal infections by Legionella and Listeria.
News, September 07, 2011
Alert FDA Strengthens Kidney Risk Warning for Reclast In light of more fatal cases of acute renal failure, the agency is revising the label of zoledronic acid when used for osteoporosis.
News, September 01, 2011
Alert Atypical Antipsychotic Linked to Life-Threatening Reactions The FDA has issued a warning about the atypical antipsychotic Saphris, which has been linked to serious allergic reactions.
News, September 01, 2011
Alert Eye Problems From Repackaged Bevacizumab Some patients treated with repackaged bevacizumab for neovascular age-related macular degeneration have developed eye infections, and some have gone blind, the FDA warned today.
News, August 31, 2011
FDA Approves Multicolor Pattern Scan Laser for Eye Surgery A new scan laser photocoagulator allows eye surgeons to choose 1 or more of 3 popular laser colors.
News, August 30, 2011
FDA Approves New Drug for Advanced NSCLC The FDA has approved crizotinib, a novel agent that targets ALK, for the treatment of late-stage non-small cell lung cancer.
News, August 26, 2011
FDA Approves Tapentadol for Chronic Pain Tapentadol extended release, already approved for acute pain, has now been given the go ahead for chronic pain.
News, August 26, 2011
FDA Approves New Drug for Hereditary Angioedema Icatibant injection, now indicated for acute attacks in adults aged 18 years and older, can reduce attack symptoms by half in 2 hours, studies show.
News, August 25, 2011

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