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Government Agencies FDA

  • A Betamorph E-Cigs employee exhales vapor while smoking an electric cigarette at the company's store in Albuquerque, New Mexico,

    E-cigarettes are now the most commonly used tobacco product among people under 18, NBC News reports.

  • Following approval from the Food and Drug Administration, Phase I clinical trials will start in the first half of this year, the company said on Monday. Its first such "off-the-shelf" cell therapy UCART19, which is being developed with Servier and Pfizer, is now being tested in Phase I trials in Britain for acute lymphoblastic leukaemia and chronic lymphocytic...

  • Feb 2- The U.S. Food and Drug Administration on Thursday expanded the use of Bristol-Myers Squibb Co's Opdivo to include treatment of urothelial carcinoma, the most common type of bladder cancer. Investors were disappointed last month when Bristol-Myers said it would not seek accelerated FDA approval for a combination of Opdivo and another immunotherapy,...

  • Pharmaceuticals health care

    Trump's promise to "streamline the FDA" could in fact be unattainable, NBC News reports.

  • Laboratory analysis found amounts of belladonna, a toxic substance, that sometimes far exceeded the amount claimed on the label of these teething tablets, the FDA said. The FDA asked Los Angeles- based Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall the products from the market, but said the company did not agree to the recall.

  • Jan 27- The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. The FDA asked Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall its homeopathic teething tablets from the market.

  • Jan 27- The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. The FDA asked Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall its homeopathic teething tablets from the market.

  • Jan 27- The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. The FDA asked Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall its homeopathic teething tablets from the market.

  • Jan 27- The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. The FDA asked Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall its homeopathic teething tablets from the market.

  • Jan 27- The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. The FDA asked Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall its homeopathic teething tablets from the market.

  • Jan 27- The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. The FDA asked Standard Homeopathic Co, the manufacturer of Hyland's teething products, to recall its homeopathic teething tablets from the market.

  • "The FDA's long-overdue response leaves key questions unanswered about the performance and effectiveness of the FDA's Office of Criminal Investigations," House of Representatives Energy and Commerce Committee Chairman Greg Walden told Reuters in a statement. An FDA spokeswoman did not have an immediate comment. Reuters also reported on how the FDA...

  • ZURICH, Jan 25- The Novartis copy of Amgen's blockbuster psoriasis drug Enbrel will not go on sale before 2018 at the earliest because of the U.S. company's patent protection challenge, the Swiss drugmaker's head of generics told Reuters. Though the U.S. Food and Drug Administration has approved the biosimilar copy of Enbrel, called Erelzi, for rheumatoid...

  • Jan 19- The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation. However, the safety and effectiveness of the drug have not been established in patients less than 18 years of age, the FDA said. The company's shares were marginally down at $6.40 in extended trading.

  • File photo: a researcher in a Bristol-Myers Squibb laboratory.

    The Fast Money traders discuss whether the pharmaceutical company will be acquired.

  • File photo: a researcher in a Bristol-Myers Squibb laboratory.

    The lung cancer treatment is still expected to receive approval in the second half of 2018.

  • Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours. The pharmaceutical company cited "a review of data available at this time" for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy. Merck said the FDA would decide by...

  • Jan 19- Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for its combination of two immunotherapy drugs as an initial treatment for lung cancer. Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours. Merck said the U.S. Food and Drug Administration would...

  • Jan 19- The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation. However, the safety and effectiveness of the drug have not been established in patients less than 18 years of age, the FDA said. The company's shares were marginally down at $6.40 in extended trading.

  • Jan 19- The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation. CIC is a type of gastrointestinal disorder where individuals have difficult and infrequent bowel movements. Synergy's plecanatide is expected to generate peak sales of $348.8 million by 2021,...