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Government Agencies FDA

  • May 17- Concert Pharmaceuticals Inc said on Wednesday the U.S. Food and Drug Administration imposed a clinical hold on a mid-stage trial testing the company's drug to treat alopecia areata, a type of hair loss.

  • Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website. The warnings include a boxed warning, reserved for the most serious possible adverse events, the...

  • May 12- Eli Lilly and Co said on Friday its experimental treatment met the main goal of reducing the number of monthly migraine headache days compared to a placebo in three late-stage studies. Lilly said it would submit a marketing application to the U.S. Food and Drug Administration for the drug in the second half of 2017.. About 40 million Americans suffer from...

  • May 12- Eli Lilly and Co said on Friday its experimental migraine treatment met the main goal of reducing the number of monthly migraine headache days compared to a placebo in three late-stage studies. Lilly will submit a marketing application to the U.S. Food and Drug Administration for the drug, galcanezumab, in the second half of 2017.. Galcanezumab was being...

  • Merck CEO: We're doing the right studies to make KeyTruda broadly available

    Merck CEO Kenneth Frazier speaks to CNBC's Meg Tirrell about the FDA's approval of the company's lung cancer treatment KeyTruda and the general fight against cancer.

  • LONDON, May 11- Hikma Pharmaceuticals said on Thursday that U.S. regulators had decided not to approve its generic copy of GlaxoSmithKline's blockbuster lung drug Advair at this time, due to' major' issues with its application. The company said there was a low likelihood of approval this year. The U.S. Food and Drug Administration has already delayed approval of...

  • Mylan President Rajiv Malik said the FDA was asking it to comply with standards set out in draft guidance the agency issued, but that it believes it is not required to do so. Malik said the company could not comment further on the length of the delay for approval until it meets with the FDA to discuss their disagreement, but that the FDA had designated it as requiring...

  • Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements. The Senate voted 57-42 in favor of Gottlieb, a conservative physician and former deputy FDA commissioner under George W. Bush, who supporters say is...

  • Gottlieb, a physician and former deputy FDA commissioner during the George W. Bush administration, is seen as competent and knowledgeable. Gottlieb is expected to move quickly to implement FDA mandates in the recently passed 21st Century Cures Act, which is, among other things, designed to speed the drug approval process by relaxing certain clinical trial...

  • May 9- U.S. health regulators on Tuesday granted accelerated approval for Pfizer Inc's immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany's Merck KGaA. In March, Bavencio was approved by the Food and Drug Administration to treat a rare skin cancer...

  • The FDA had identified issues related to long-term safety data, the company said. "We... respectfully disagree with the FDA's decision," TherapeuticsMD's Chief Executive Robert Finizio said, adding that there are multiple paths forward to address the concerns. Last month, the company said it received a letter from the FDA identifying deficiencies in the drug's...

  • May 8- Women's healthcare company TherapeuticsMD Inc said on Monday the U.S. Food and Drug Administration had rejected the drug developer's application to market its drug to treat vaginal pain. The FDA had identified issues relating to long-term safety data, the company said. The drug, TX-004HR, was being developed to treat moderate-to-severe vaginal pain...

  • Notice came shortly after the U.S. Department of Agriculture relaxed some school lunch rules that were part of former first lady Michelle Obama's signature effort to fight childhood obesity. The Food and Drug Administration late on Monday extended the compliance date for the calorie labeling rule from May 5, 2017, to May 7, 2018, to enable further...

  • *AstraZeneca sets durvalumab price at $15,000/ month. Leerink analyst Seamus Fernandez sees durvalumab capturing a modest 10 percent of the estimated $2.3 billion global bladder cancer market, while AstraZeneca in 2014 put the drug's peak sales in all cancers at $6.5 billion, including combination use. The U.S. Food and Drug Administration said late on Monday...

  • *AstraZeneca sets durvalumab price at $15,000/ month. May 1- U.S. regulators have approved AstraZeneca's key immunotherapy drug durvalumab as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of dollars. The U.S. Food and Drug Administration said on Monday it granted accelerated...

  • May 1- The U.S. Food and Drug Administration on Monday granted accelerated approval to AstraZeneca Plc's immuno-oncology drug to treat a type of bladder cancer in patients whose disease progressed despite chemotherapy. The FDA also approved a complementary diagnostic from Roche Holding AG to assess whether the PD-L1 protein is expressed in urothelial...

  • May 1- The U.S. Food and Drug Administration on Monday granted accelerated approval to AstraZeneca Plc's immuno-oncology drug to treat a type of bladder cancer in patients whose disease progressed following chemotherapy.

  • April 28- The U.S. Food and Drug Administration approved Novartis AG's Rydapt as an initial treatment for acute myeloid leukemia as well as certain other blood disorders, the agency said on Friday. Rydapt is approved to be used along with chemotherapy to treat adults newly diagnosed with AML and carrying a specific genetic mutation called FLT3, the FDA said.

  • Prescription bottles

    Nursing homes in the U.S. routinely dispose of leftover meds that could benefit other Americans with limited health care, ProPublica reports.

  • April 28- The U.S. Food and Drug Administration approved Novartis AG's Rydapt as an initial treatment for acute myeloid leukemia as well as certain other blood disorders, the agency said on Friday. Rydapt is approved to be used along with chemotherapy to treat adults newly diagnosed with AML and carrying a specific genetic mutation called FLT3, the FDA said.