GO
Loading...

FDA

More

  • WASHINGTON, June 27- The U.S. Food and Drug Administration said on Friday it has approved MannKind Corp's inhaled insulin, Afrezza, capping an arduous journey for the company and its octogenarian founder, Alfred Mann. It acts more rapidly than injectable insulins such as Eli Lilly and Co's Humalog and Novo Nordisk's NovoLog.

  • WASHINGTON, June 27- The U.S. Food and Drug Administration said on Friday it has approved MannKind Corp's inhaled insulin Afrezza, capping an arduous journey for the company and its octogenarian founder, Alfred Mann. It acts more rapidly than traditional injected insulin sold by Eli Lilly and Co and Denmark's Novo Nordisk.

  • Gordon Gund, Gund Investment Corp. chairman & CEO, who lost his sight 40 years ago, discusses the promising work being done to find a cure for blindness.

  • Finding the cure for blindness     Friday, 27 Jun 2014 | 7:42 AM ET

    Gordon Gund, Gund Investment Corp. chairman & CEO, who lost his sight 40 years ago, discusses his goal to raise $100 million to fund research for a cure for blindness.

  • FDA ruling a win for paraplegic community     Friday, 27 Jun 2014 | 6:52 AM ET

    Larry Jasinski, ReWalk Robotics CEO, discusses how the FDA's decision will likely improve the lives of wheelchair bound people. This is such groundbreaking technology that the FDA put a new classification code for this product, explains Jasinski.

  • WASHINGTON/ MUMBAI, June 27- India's Ranbaxy Laboratories Ltd has received approval from the U.S. Food and Drug Administration to launch a cheaper copy of Novartis AG's blood pressure pill Diovan, bolstering its outlook after a raft of regulatory bans for poor production quality at its India facilities dented investor sentiment.

  • U.S. FDA seeks ideas for nanotech use in livestock feed Thursday, 26 Jun 2014 | 1:28 PM ET

    CHICAGO, June 26- The U.S. Food and Drug Administration is opening the door for livestock feed manufacturers and pharmaceutical companies to roll out nanotechnology products that could make animals gain weight faster or absorb medications more quickly.

  • Representative Bob Goodlatte, chairman of the House Judiciary Committee, and Senator Lamar Alexander, ranking member on the Senate's Committee on Health, Education, Labor& Pensions, wrote to the White House's Office of Management and Budget requesting justification for the cost-benefit analysis on the proposed rule by the Food and Drug Administration.

  • "I don't think anybody knows what do," said Michael F. Jacobson, executive director of CSPI, which calculated the numbers using data it obtained from the FDA. The FDA said it has been studying the drinks for several years and is evaluating the deaths. " This does not necessarily mean that the energy drink caused the death, "an FDA spokesperson said.

  • WASHINGTON, June 25- An advisory panel to the U.S. Food and Drug Administration recommended on Wednesday that AstraZeneca Plc be required to submit further clinical data before its experimental ovarian cancer drug is approved.

  • WASHINGTON, June 25- An advisory panel to the U.S. Food and Drug Administration recommended on Wednesday that AstraZeneca Plc be required to submit further clinical data before its experimental ovarian cancer drug is approved.

  • FDA warning: Popular acne products cause reactions Wednesday, 25 Jun 2014 | 2:09 PM ET

    The U.S. Food and Drug Administration warned that popular acne products can cause rare but serious and life-threatening allergic reactions.

  • June 25- The U.S. Food and Drug Administration warned on Wednesday that popular acne products such as Proactiv and Neutrogena can cause rare but serious and life-threatening allergic reactions.

  • WASHINGTON, June 24- A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards.

  • WASHINGTON, June 24- The U.S. Food and Drug Administration has warned GlaxoSmithKline Plc that one of its plants in Canada violated quality control standards during the manufacture of its influenza vaccine Flulaval.

  • June 24- The U.S. Food and Drug Administration said an unit of GlaxoSmithKline Plc violated quality requirements during the manufacture of influenza vaccine Flulaval. In a warning letter, the FDA said the company had failed to take appropriate steps to prevent microbiological contamination of drugs, among other violations.

  • Cubist advances Sivextro     Monday, 23 Jun 2014 | 3:38 PM ET

    Michael Bonney, Cubist Pharmaceuticals CEO, discusses the FDA's approval of Sivextro, a new antibiotic designed to treat skin infections. Bonney also explains why so many pharma companies have left the antibiotic space.

  • June 23- AstraZeneca Plc's experimental ovarian cancer drug, olaparib, showed an 83 percent reduction in the risk of disease progression, but a U.S. Food and Drug Administration staff review has questioned whether the result could be reproduced.

  • 23andMe takes step on path to FDA approval Friday, 20 Jun 2014 | 3:57 PM ET

    Genetics startup 23andMe said it is one step closer to resuming sales of its full-fledged health product.

  • FDA asks for wider warning on testosterone products Friday, 20 Jun 2014 | 8:31 AM ET

    The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia.