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Government Agencies FDA

  • A Food and Drug Administration advisory panel voted 10-0 on Wednesday in favor of the leukemia treatment developed by the University of Pennsylvania and Novartis Corp. The FDA usually follows recommendations from its expert panels, but isn't obligated to do so. Malcolm A. Smith of the National Cancer Institute. "Our daughter was going to die and now she leads a...

  • *FDA to review Novartis's CTL019 on Wednesday. ZURICH, July 11- Two decades ago in a Memphis, Tenn., hospital lab, cancer scientist Dario Campana and his team were hunting for a new way to fight deadly acute lymphoblastic leukemia. "Our first tests convinced us these T cells were special," Campana, now a scientist at the National University Cancer Institute in Singapore,...

  • July 10- The U.S. Food and Drug Administration will ask a panel of advisors to focus on the safety of Novartis AG's experimental gene therapy drug when it meets to review the product on Wednesday. If approved, the drug, tisagenlecleucel, would be the first gene therapy to be approved in the United States. The FDA is not obliged to follow the recommendations of its...

  • July 10- The U.S. Food and Drug Administration will ask a panel of advisors to focus on the safety of Novartis AG's experimental gene therapy drug when it meets to review the product on Wednesday. The FDA is not obliged to follow the recommendations of its advisors but typically does so. The FDA said it is not asking the panel to focus on whether the drug works, as it...

  • July 10- The U.S. Food and Drug Administration will ask a panel of advisors to focus on the safety of Novartis AG's experimental gene therapy drug when it meets to review the leukemia treatment on Wednesday. The keenly anticipated preliminary review by the U.S. Food and Drug Administration, posted on its website on Monday, comes two days ahead of the advisory panel...

  • July 10- Concert Pharmaceuticals Inc said on Monday the U.S. Food and Drug Administration lifted a clinical hold on a trial testing its therapy for alopecia areata, a type of hair loss. The FDA had imposed a hold on the mid-stage study in May and asked for more data before Concert could proceed with dosing patients. The disease affects about 4.6 million people in the...

  • July 10- Concert Pharmaceuticals Inc said on Monday the U.S. Food and Drug Administration lifted the clinical hold on a mid-stage study testing its drug to treat alopecia areata, a type of hair loss.

  • In a letter Saturday, the New York Democrat asked the Food and Drug Administration to investigate the use of caffeine in inhalable food products such as so-called Coco Loko. Schumer, the Senate minority leader, says there are too many unanswered questions about a product pitched under the innocent-sounding name of chocolate. Manufacturer Legal Lean Co....

  • *FDA requested withdrawal of drug in June. July 6- Endo International Plc said on Thursday it agreed to withdraw its long-acting opioid painkiller Opana ER from the market after the U.S. Food and Drug Administration declared its benefit did not outweigh public health risks associated with opioid abuse. The FDA called last month for the drug to be withdrawn after...

  • *FDA requested withdrawal of drug in June. Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention. Endo on Thursday said it expects to incur a pre-tax impairment charge of about $20 million in the second...

  • July 5- Merck& Co Inc said on Wednesday the U.S. Food and Drug Administration had placed a clinical hold on three multiple myeloma studies testing its immunotherapy drug, Keytruda, in combination with other therapies. The health regulator said the risks of the combination studies, Keynote-183, Keynote-185 and Keynote-023, outweigh any potential benefit for...

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  • WASHINGTON, June 29- The U.S. Food and Drug Administration plans to reorganize its drug review staff and create a SWAT team to eliminate a backlog of requests for rare disease drug designation, it said on Thursday. In 2016 the FDA received 568 new requests for orphan drug designation, more than double the number received in 2012.. On Tuesday the FDA released a list of...

  • WASHINGTON, June 29- The U.S. Food and Drug Administration plans to reorganize its drug review staff and create a SWAT team to eliminate a backlog of drugs for rare diseases and speed reviews of future applications, it said on Thursday. In 2016 the FDA received 568 new requests for orphan drug designation, more than double the number received in 2012..

  • Martin Shkreli arrives to federal court in Brooklyn on June 27th, 2017.

    "We don't play a role in drug pricing, but we do affect drug competition," Dr. Scott Gottlieb tells CNBC.

  • FDA's Scott Gottlieb on generic drug competition

    FDA Commissioner Scott Gottlieb discusses pricing and competition in the pharmaceutical industry and what policy steps can be taken to promote low-cost generic drugs.

  • WASHINGTON, June 23- The U.S. Food and Drug Administration on Friday approved a new oral blood-thinner made by Portola Pharmaceuticals Inc to prevent deep vein thrombosis and pulmonary embolisms in acutely ill patients who are not undergoing surgery. Analysts on average expect the drug to generate sales of $313 million by 2020, rising to more than $1 billion...

  • FDA approves Portola's blood-thinning drug

    CNBC's Morgan Brennan reports on the FDA approving Portola's blood-thinning drug and the company's stock reaction.

  • The Food and Drug Administration approved Rituxan Hycela to treat adults with follicular lymphoma, diffuse large B-cell lymphoma or chronic lymphocytic leukemia, Roche's Genentech unit said. The FDA approval is based on clinical studies that demonstrated that subcutaneous administration of Rituxan Hycela resulted in similar levels of the antibody in...

  • WASHINGTON, June 21- The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from "gaming" the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place...