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  • April 15- U.S. health regulators have approved four Boston Scientific Corp implantable devices for heart patients, including a next generation of smaller defibrillators to treat abnormal heart rhythms, the company said on Tuesday.

  • FDA OKs Merck tablet to reduce grass allergies Tuesday, 15 Apr 2014 | 3:15 PM ET

    WHITEHOUSE STATION, N.J.— Merck& Co. says the Food and Drug Administration has approved its new tablet for grass allergies, Grastek, for patients five to 65 years old. Merck, based in Whitehouse Station, N.J., will market the tablet in North America. Its partner, ALK-Abello, sells it in Europe as Grazas.

  • FDA approves injectable diabetes drug from Glaxo Tuesday, 15 Apr 2014 | 3:08 PM ET

    WASHINGTON— The Food and Drug Administration said Tuesday it approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes. The FDA said it approved the new drug based on eight trials including more than 2,000 patients.

  • April 15- The U.S. Food and Drug Administration approved GlaxoSmithKline Plc's Tanzeum injection for treating adults with type 2 diabetes, in combination with diet and exercise. However, it is unknown whether Tanzeum causes thyroid C-cell tumors, the FDA said on its website.

  • DNA alternative to Pap smear sparks medical debate Tuesday, 15 Apr 2014 | 11:21 AM ET

    While such technology has been available for years, Roche now wants the Food and Drug Administration to approve its test as a first-choice option for cervical cancer screening, bypassing the decades-old Pap test.

  • FDA approves GSK's Tanzeum to treat type 2 diabetes Tuesday, 15 Apr 2014 | 10:35 AM ET

    April 15- The U.S. Food and Drug Administration approved GlaxoSmithKline Plc's Tanzeum injection for treating adults with type 2 diabetes, in combination with diet and exercise. However, it is unknown whether Tanzeum causes thyroid C-cell tumors, the FDA said on its website.

  • April 14- Merck& Co said the U.S. Food and Drug Administration on Monday approved its grass pollen allergy drug Grastek, becoming the second such immunotherapy treatment to be given the go-ahead in recent weeks.

  • FDA halts Halozyme's pancreatic cancer study Wednesday, 9 Apr 2014 | 8:32 AM ET

    April 9- Halozyme Therapeutics Inc said the U.S. Food and Drug Administration ordered a halt on a study of its drug delivery system in pancreatic cancer patients, barely a week after the company voluntarily stopped the trial. The company's shares fell about 3 percent to $8.06 in trading before the bell.

  • Only manufactures that do not add sugar, corn syrup or other sweeteners should label their products as pure "honey," the FDA said in draft guidelines posted online. But just 149 million pounds were produced in the United States last year, U.S. Department of Agriculture data showed.

  • FDA: Honey with any added sweeteners isn't honey Tuesday, 8 Apr 2014 | 10:27 AM ET

    The Food and Drug Administration is taking steps to ensure that shoppers who buy honey are getting the real deal. New guidance issued Tuesday would prevent food companies from adding sugar or other sweeteners to pure honey and still calling it "honey."

  • Zohydro maker sues to block Massachusetts ban Monday, 7 Apr 2014 | 5:15 PM ET

    Zogenix filed suit in U.S. District Court in Massachusetts on Monday requesting that the court temporarily stop Massachusetts Governor Deval Patrick's executive order. The San Diego- based company argues in its lawsuit that Governor Patrick's order is at odds with the U.S. Food and Drug Administration, which approved use of Zohydro for severe pain in October.

  • April 7- MannKind Corp said the U.S. Food and Drug Administration extended the review date of its inhaled insulin treatment by three months, sending the company's shares down as much as 22 percent before the bell.

  • *Ranbaxy shareholders to get 0.8 Sun Pharma share for each Ranbaxy share. Ranbaxy, India's No.1 drugmaker by sales and 63.4 percent held by Daiichi Sankyo Co Ltd, is banned from exporting drug ingredients to the United States, while Sun Pharmaceutical's Karkhadi plant is also barred from shipping products by the U.S. Food and Drug Administration.

  • April 6- Pfizer Inc's experimental breast cancer drug in a clinical trial nearly doubled the amount of time patients lived without their disease getting worse, but overall survival was not yet shown to be statistically significant, researchers said. The U.S. Food and Drug Administration has granted "breakthrough" status for palbociclib.

  • States rebel against powerful new painkiller Friday, 4 Apr 2014 | 9:58 AM ET

    The Food and Drug Administration approved the drug last fall and it hit the market last month. Harry Chen both questioned the FDA approval. "So you know, we're just saying' Hey, we understand we don't control the FDA, but we do have some influence in Vermont,'" he said.

  • April 3- The U.S. Food and Drug Administration is increasing its oversight of Chinese manufacturers of pharmaceutical ingredients to improve the safety of the U.S. drug supply chain, the director of the agency's China office, Christopher Hickey, said on Thursday.

  • E-cig rule coming 'very soon,' U.S. FDA chief says Thursday, 3 Apr 2014 | 2:36 PM ET

    WASHINGTON, April 3- The U.S. Food and Drug Administration is "pushing very hard" to release a proposed rule that would establish its authority over e-cigarettes, the head of the agency said on Thursday amid concerns the products pose a risk to children.

  • FDA approves easy-to-use heroin overdose antidote Thursday, 3 Apr 2014 | 11:07 AM ET

    The Food and Drug Administration on Thursday approved an easy-to-use device that automatically injects the right dose of an overdose antidote named naloxone before an ambulance arrives. The FDA said Evzio's design makes it easy for anyone to administer.

  • April 2- MannKind Corp's shares doubled on Wednesday, after an advisory committee to the U.S. health regulator recommended approval of the drug developer's inhaled insulin treatment.

  • April 1- The U.S. Food and Drug Administration found that a drug ingredient manufactured at a GlaxoSmithKline Plc plant in Ireland was contaminated and said the company did not take sufficient action to resolve the problems.

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