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  • Jan 26- The U.S. Food and Drug Administration approved Rockwell Medical Inc's drug for treating iron loss in chronic kidney disease patients on dialysis, sending the company's shares up about 15 percent in premarket trading. Samimy said she expected Triferic to hit peak sales of $200 million- $250 million in the United States. Rockwell estimates the market for...

  • Jan 22- A panel of experts on Thursday voted to recommend that U.S. health regulators approve Astellas Pharma Inc's drug for the treatment of rare, often fatal invasive fungal infections that can target patients with blood cancers. The Astellas medicine, which would be sold under the proposed brand name Cresemba, was granted Orphan Drug status by the FDA, which is...

  • Jan 21- The U.S. Food and Drug Administration approved Novartis AG's injectable drug, Cosentyx, to treat adults with a moderate to severe skin disease called plaque psoriasis. Eli Lilly and Co will begin marketing its IL-17 inhibitor ixekizumab in the first half of 2015, while Amgen Inc and AstraZeneca Plc's brodalumab reported positive results from a...

  • FDA approves Novartis's psoriasis drug Wednesday, 21 Jan 2015 | 12:49 PM ET

    Jan 21- The U.S. Food and Drug Administration said it approved Novartis AG's drug to treat adults with moderate to severe plaque psoriasis.

  • WASHINGTON, Jan 14- The U.S. Food and Drug Administration said on Wednesday it has approved a new device to treat obesity, the first since 2007, sending shares of its maker, EnteroMedics Inc, up as much as 74 percent. Known as the Maestro Rechargeable System, the device controls hunger and feelings of fullness by targeting the nerve pathway between the brain and the...

  • FDA approves EnteroMedics' novel device to treat obesity Wednesday, 14 Jan 2015 | 10:47 AM ET

    WASHINGTON, Jan 14- The U.S. Food and Drug Administration said on Wednesday it has approved a new device to treat obesity, the first since 2007.. Known as the Maestro Rechargeable System, the device, made by EnteroMedics Inc, controls hunger and feelings of fullness by targeting the nerve pathway between the brain and the stomach. But an FDA advisory panel...

  • Jan 13- Antares Pharma Inc said the U.S. Food and Drug Administration has asked for additional safety data on its testosterone drug after a patient developed hives in a mid-stage trial. The FDA has become more cautious about approving testosterone drugs after it found late last year that more than a fifth of the patients prescribed such drugs did not get their...

  • Jan 13- Antares Pharma Inc said the U.S. Food and Drug Administration has asked for additional safety data on its testosterone drug after a patient developed hives in a mid-stage trial. Hives is an allergic skin reaction that causes red, itchy bumps on the skin. The FDA has asked for data on 350 patients exposed to the drug, QuickShot Testosterone.

  • Jan 12- Drug developer Arrowhead Research Corp said the U.S. Food and Drug Administration placed the company's experimental hepatitis B treatment on partial clinical hold, seeking additional data from the drug's mid-stage study. The company's shares plunged 22 pct premarket on Monday after the FDA also asked the company to reduce the dosage of the drug,...

  • Jan 12- The U.S. Food and Drug Administration approved AbbVie Inc's treatment for Parkinson's disease, three months ahead of the scheduled review date. Last week, the FDA approved Impax Laboratories Inc's Parkinson's drug, Rytary, after rejecting it twice. Other companies developing drugs for the disease include NeuroDerm Ltd, Acorda Therapeutics Inc and...

  • AbbVie wins U.S. approval for Parkinson's treatment Monday, 12 Jan 2015 | 8:25 AM ET

    Jan 12- The U.S. Food and Drug Administration approved AbbVie Inc's treatment for Parkinson's disease, three months ahead of the scheduled review date. The treatment, Duopa, is administered using a small portable infusion pump that delivers the drug directly to the small intestine. The combination treatment, comprising carbidopa and levodopa, is the first to be...

  • Jan 12- Drug developer Arrowhead Research Corp said the U.S. Food and Drug Administration asked the company to reduce the dosage of its experimental Hepatitis B treatment and requested additional data from the drug's mid-stage trial. The company's shares fell 19 pct premarket on Monday. Arrowhead said its ongoing mid-stage trial would continue as planned...

  • 'Dirty' discovery in antibiotics  Thursday, 8 Jan 2015 | 1:31 PM ET

    Superbugs are one of the biggest public health crises facing the world right now. CNBC's Meg Tirrell reports nature is sparking hope for scientists.

  • FDA paves way for cheaper cancer drug copies  Thursday, 8 Jan 2015 | 1:28 PM ET

    CNBC's Meg Tirrell reports an FDA advisory panel unanimously recommended approval of what would be the first generic biologic drug in the U.S.

  • Jan 7- A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, setting the stage for the regulator's first approval of a biosimilar. The biosimilar could be priced at the same level as Neupogen, but cost to insurers and consumers would be lower, Novartis executives...

  • Jan 7- A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, paving the way for the regulator's first approval for a biosimilar. The injectable biologic, Neupogen, prevents infections in breast cancer patients undergoing chemotherapy, which reduces their white...

  • Jan 7- Zafgen Inc said a mid-stage study showed its experimental drug reduced weight in patients obese due to damage to a part of the brain. Vivus Inc's Qsymia, Arena Pharmaceuticals Inc's Belviq and Orexigen Therapeutics Inc's Contrave appear to work by signaling the brain, but their exact mechanism of action is unknown. The U.S. Food and Drug Administration...

  • Jan 6- CytRx Corp said interim data showed its experimental brain cancer drug was effective in a mid-stage study and a partial clinical hold on enrollment could be lifted this month. The company has provided the FDA with a package of information and expects to hear back from the agency later this month, CytRx Chief Executive Steven Kriegsman told Reuters.

  • Jan 6- The U.S. Food and Drug Administration approved the first dermal filler to treat scarring caused by acne, the most common skin disorder in the United States afflicting 40-50 million people. Bellafill, developed by privately held Suneva Medical Inc, is made primarily of bovine collagen. Ava Shamban, an assistant clinical professor of dermatology at UCLA, who...

  • Jan 6- The U.S. Food and Drug Administration approved the first dermal filler to treat scarring caused by acne, the most common skin disorder in the United States afflicting 40-50 million people. Bellafill, developed by privately held Suneva Medical Inc, has been developed to treat moderate to severe acne scars on the cheeks of patients over the age of 21..