×

Government Agencies FDA

  • May 26- Kite Pharma Inc on Friday said the U.S. Food and Drug Administration will review its experimental drug axicabtagene ciloleucel on a priority basis as a treatment for advanced non-Hodgkin lymphoma, a cancer that starts in white blood cells. The FDA's decision is expected by Nov. 29. Kite announced in March that it had completed the FDA filing.

  • FDA to publish list of drugs with no generic competitor

    CNBC's Meg Tirrell reports on the FDA planning to create a list of drugs with no generic competitor to increase competition.

  • Puma Biotech spikes after FDA support of breast cancer drug

    CNBC's Meg Tirrell reports on Puma's stock spike after the FDA board votes in support of its breast cancer drug.

  • The recall covers the external power supply controller for the HeartMate II, made by Abbott Laboratories' Thoratec unit and distributed from July 2012 until last March. The Food and Drug Administration on Wednesday said 70 malfunctions have been reported, all after patients switched to a backup unit on their own. The FDA is warning users to only change the...

  • WASHINGTON, May 24- Puma Biotechnology Inc's experimental breast cancer drug reduces the risk of the disease's recurrence and should be approved, a U.S. Food and Drug Administration advisory committee concluded on Wednesday, sending the stock up as much as 30 percent. The FDA is not obliged to follow the recommendations of its advisory panels, but typically...

  • WASHINGTON, May 24- Puma Biotechnology Inc's experimental breast cancer drug reduces the risk of disease recurrence and should be approved, an advisory committee to the U.S. Food and Drug Administration concluded on Wednesday. The FDA is not obliged to follow the recommendations of its advisory panels, but typically does so. Grzegorz Nowakowski, associate...

  • WASHINGTON, May 24- U.S. Senate Republican Leader Mitch McConnell told Reuters on Wednesday he expects bipartisan support for approval of a bill authorizing taxpayer and industry funding for the U.S. Food and Drug Administration. The bill to reauthorize the Prescription Drug User Fee Act would let the FDA continue to collect hundreds of millions of dollars...

  • WASHINGTON, May 24- Puma Biotechnology Inc's experimental breast cancer drug reduces the risk of disease recurrence and should be approved, an advisory committee to the U.S. Food and Drug Administration concluded on Wednesday. The FDA is not obliged to follow the recommendations of its advisory panels, but typically does so. Grzegorz Nowakowski, associate...

  • The review, posted on Monday on the FDA's website, sent the company's shares up as much as 84 percent to $69.35 from $37.80 before dropping back to $53.75 in afternoon trading. A panel of outside advisers to the FDA will meet on Wednesday to discuss the drug and recommend whether it should be approved. The FDA is not obliged to follow the advice of its advisers but...

  • The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the Food and Drug Administration. But the new safety data, which cropped up in an otherwise successful trial, will have to be taken into consideration, delaying any FDA decision and leaving the product's future uncertain. The news is a blow for...

  • May 22- Puma Biotechnology's experimental breast cancer drug appears to be effective, though there is some uncertainty as to the magnitude of the benefit, a preliminary review by the U.S. Food and Drug Administration concluded on Monday. The review sent the company's shares up as much as 84 percent to $69.35 in early trading before they dropped back to $52.35.

  • May 22- Shares of Puma Biotechnology Inc surged about 80 percent on Monday after the U.S. Food and Drug Administration staffers concluded after a preliminary review that the company's experimental breast cancer drug was effective. The FDA has scheduled an advisory committee meeting on May 24 to discuss the company's breast cancer drug.

  • The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the Food and Drug Administration. But the new safety data, which cropped up in an otherwise successful trial, will have to be taken into consideration, delaying any FDA decision and leaving the product's future uncertain. The news is a blow for...

  • The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the Food and Drug Administration. But the new safety data, which cropped up in an otherwise successful trial, will have to be taken into consideration, delaying any FDA decision. The drug is also being considered for approval in Canada and Japan,...

  • The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the Food and Drug Administration. But the new safety data, that cropped up in an otherwise successful trial, will have to be taken into consideration, delaying any FDA decision. The drug is also being considered for approval in Canada and Japan, the...

  • MIAMI— A Miami company is recalling 6,000 pounds of cheese from California stores because of possible bacterial contamination. A Food and Drug Administration news release says the affected Queso Duro Blando brand cheese, distributed by La Nica Products Inc., has the potential to be contaminated with Listeria monocytogenes. The recall followed testing by...

  • *FDA does not cite safety concerns. The FDA had asked for more data before Concert Pharma could proceed with dosing patients in the mid-stage trial, but the agency did not raise any concerns over the safety of Concert's drug, the drug developer said. The FDA will review the company's response within 30 days of submission and, if positive, the trial will be allowed to...

  • U.S. health agencies on Wednesday warned that certain blood tests for lead poisoning may give results lower than the actual level of lead. As a result, some children under 6, along with pregnant and nursing women, may need retesting, the Food and Drug Administration and Centers for Disease Control and Prevention said. The lead poisoning tests are made by Magellan...

  • *FDA does not cite safety concerns. The FDA had asked for more data before Concert Pharma could proceed with dosing patients in the mid-stage trial, but the agency did not raise any concerns with the safety of Concert's drug, the drug developer said. Concert Pharma's drug, CTP-543, is competing with Aclaris Therapeutics Inc's ATI-50001 to be the first FDA- approved...

  • The warning is based on data that indicates that the tests, made by Magellan Diagnostics, could throw up results that are lower than the actual level of lead in the blood, according to the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. "The FDA is deeply concerned... and is warning laboratories and health care professionals that...