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  • U.S. FDA approves Bristol-Myers' HIV drug Thursday, 29 Jan 2015 | 5:44 PM ET

    Jan 29- The U.S. Food and Drug Administration has approved the sale of Evotaz, a once-daily combination pill to treat HIV made by Bristol-Myers Squibb Co, the company said on Thursday. The new drug combines Reyataz, also known as atazanavir, a Bristol-Myers' protease inhibitor, with cobicistat, a boosting agent produced by Gilead Sciences Inc..

  • The regulator's decision, which comes in over two months ahead of its review date, represents a fourth indication for the drug, sold by Johnson& Johnson and Pharmacyclics Inc. Although WM occurs only in up to 1,500 patients in the United States each year, the approval highlights the strength of the Imbruvica franchise, Roth Capital Partner's Joseph Pantginis...

  • FDA expands use of Imbruvica to treat rare form of cancer Thursday, 29 Jan 2015 | 11:29 AM ET

    Jan 29- The U.S. Food and Drug Administration said it cleared an expanded use of Imbruvica to treat Waldenström's macroglobulinemia, a rare form of cancer that begins in the body's immune system. The approval represents a fourth indication for the drug, sold by Johnson& Johnson and Pharmacyclics Inc, since its initial approval in November 2013.

  • WASHINGTON, Jan 28- U.S. lawmakers proposed a bill on Wednesday that would create a single food safety agency by bringing together the oversight functions of the Food and Drug Administration, U.S. Department of Agriculture and other agencies. Democratic Senator Richard Durbin from Illinois and Representative Rosa DeLauro, a Democrat from Connecticut, told...

  • Jan 27- Medical device maker Abiomed Inc raised its full-year revenue forecast and said the U.S. Food and Drug Administration had approved its heart pump, sending its stock nearly 32 percent in extended trading. Abiomed's heart pump, Impella RP, helps blood circulation for up to 14 days in patients who develop acute right heart failure following implantation,...

  • Jan 27- Medical device maker Abiomed Inc raised its full-year revenue forecast and said it had received U.S. approval for its heart pump, sending its stock soaring 24 percent after-hours. Abiomed raised its revenue estimate for the year ending March 31 to $223- $226 million from $209- $212 million. The company said the U.S. Food and Drug Administration had approved...

  • Robert Califf, a top cardiologist and researcher, to oversee its drug, medical device and tobacco policy in what experts said is a coup for the FDA. "This is a great catch for the FDA," said Dr. Califf has run countless clinical studies, published more than 1,000 papers, served as an FDA adviser and has twice been interviewed as a potential FDA commissioner.

  • Jan 26- The U.S. Food and Drug Administration said it approved Teva Pharmaceutical Industries Ltd's generic version of AstraZeneca Plc's blockbuster heartburn drug Nexium, the agency's first such approval for the drug. Nexium raked in about $1.9 billion in global sales in the first half of 2014, according to AstraZeneca's latest earnings statement.

  • FDA names cardiologist to senior leadership position Monday, 26 Jan 2015 | 3:37 PM ET

    Robert Califf, a cardiologist and researcher, to oversee its drug, medical device and tobacco policy, in what experts said is a coup for the FDA. He has run countless clinical studies, served on FDA advisory committees, and was rumored in 2009 to be a potential FDA commissioner before the job went to the current commissioner, Dr. "He is a guy who could very easily be FDA...

  • 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...