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Government Agencies FDA

  • WASHINGTON, July 27- Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee's antitrust subcommittee, was on the use by some brand name drug companies of a Food...

  • July 27- Amgen Inc said on Thursday the U.S. Food and Drug Administration granted priority review to the company's request to add important heart safety data to the label of its expensive injectable cholesterol drug Repatha. The FDA will decide by Dec. 2 whether to allow Amgen to include data from a major clinical trial that showed Repatha significantly cut the...

  • MEXICO CITY— Mexico's food safety agency says it is "premature" to point to Mexican papayas as the source of a salmonella outbreak in the U.S. A Thursday statement by Mexico's Agriculture Department says agency technicians have begun collecting samples from across Mexico. On Wednesday, the U.S. Food and Drug Administration said the illness had been tracked to...

  • July 26- A panel of independent advisers to the U.S. Food and Drug Administration overwhelmingly concluded on Wednesday that there is not enough evidence to support approval of Intellipharmaceutics International Inc's long-acting opioid painkiller. Toronto- based Intellipharma's painkiller, Rexista, is designed as a unique abuse-deterrent version of...

  • Panelists voted overwhelmingly against approving Intellipharmaceutics International's generic version of extended-release Oxycontin, a key drug in the U.S. opioid addiction epidemic. The FDA usually follows its advisers' advice. But the FDA advisers, a combined group of drug safety and pain management experts, voted 22-1 against recommending the FDA...

  • July 26- A panel of independent advisers to the U.S. Food and Drug Administration concluded on Wednesday that there is not enough evidence to support the approval of Intellipharmaceutics International Inc's long-acting opioid painkiller. Toronto- based Intellipharma's painkiller has been developed as a unique abuse-deterrent version of Purdue...

  • July 26- Eagle Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration declined to approve its drug Ryanodex to treat heat stroke and requested an additional clinical trial, sending its shares down 20 percent. Eagle is reviewing its options and intends to evaluate the FDA's response to proceed with the drug's development, Chief Executive...

  • July 26- Eagle Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration declined to approve its drug Ryanodex to treat heat stroke and requested an additional clinical trial. The drug, which is approved for the treatment and prevention of malignant hyperthermia, is being tested to treat exertional heat stroke, in conjunction with external...

  • July 25- Tetraphase Pharmaceuticals Inc said its lead experimental antibiotic for serious bacterial infections met the main goal in a late-stage study, sending its shares surging nearly 23 percent in after-market trading on Tuesday. The company plans to submit a marketing application for the drug to the U.S. Food and Drug Administration by the first quarter...

  • *Raises FY17 revenue forecast to $22 bln- $22.5 bln. The U.S. Food and Drug Administration in April declined to approve the drug, baricitinib, made by Lilly and partner Incyte Corp, indicating additional clinical data was needed to determine the most appropriate doses. The companies will be discussing the path forward with the agency and evaluating options for...

  • July 24- U.S. Food and Drug Administration scientists on Monday expressed concern that Intellipharmaceutics International Inc had failed to provide adequate data on the abuse potential of its long-acting opioid painkiller. In a preliminary review, FDA staffers said Intellipharma had not submitted abuse-liability study data as part of its application to...

  • July 24- U.S. Food and Drug Administration scientists on Monday raised concerns that Intellipharmaceutics International Inc failed to provide data from studies testing the abuse potential of its long-acting opioid painkiller. Both painkillers contain oxycodone- one of three leading drugs involved in prescription opioid deaths- according to the Centers...

  • July 24- U.S. Food and Drug Administration scientists on Monday raised concerns that Intellipharmaceutics International Inc failed to provide data from studies testing the abuse potential of its long-acting opioid painkiller. Canada- based Intellipharma's product, Rexista, has been developed as a unique abuse-deterrent version of Purdue Pharma's...

  • FDA's Scott Gottlieb: Opioid addiction is FDA's biggest crisis now

    Dr. Scott Gottlieb, FDA commissioner, talks about the role the FDA will play in helping to reduce opioid addiction in the U.S.

  • FDA's Scott Gottlieb: Investors need 'clarity' on policy

    Dr. Scott Gottlieb, FDA commissioner, discusses the FDA's mission, including ramping up the process of getting drugs approved.

  • FDA's Scott Gottlieb: Taking steps to bring more competition to pharma space

    Dr. Scott Gottlieb, FDA commissioner, discusses how the FDA intends to help bring down drug costs by removing obstacles that block generic versions from entering the marketplace.

  • Sarepta's drug, Exondys 51, generated sales of $35 million in the second quarter ended June 30, the company said on Wednesday. The result well exceeded analysts' average expectation of $22.9 million, according to Cowen& Co.. Exondys 51 was approved by the U.S. Food and Drug Administration in September.

  • A former Googler is hoping to use machine learning technology to prevent sudden cardiac death.

  • A scientist at Vertex Pharmaceuticals works in her laboratory in San Diego.

    Vertex is attempting to expand treatment options to about 40 percent of cystic fibrosis patients.

  • July 18- Gilead Sciences Inc said on Tuesday that the U.S. Food and Drug Administration approved its hepatitis C drug for patients who had failed to respond to prior treatments. Vosevi is the first drug to be approved for hepatitis C patients already treated with Sovaldi or other drugs, which inhibit a protein called NS5A, the FDA said in a separate release.