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Government Agencies FDA

  • June 8- The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down as much as 13 percent. "After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its...

  • *FDA had rejected a rival JAK inhibitor drug 2 months back. AbbVie's success comes almost two months after the U.S. Food and Drug Administration rejected baricitinib, a rival JAK inhibitor developed by Eli Lilly and Co and Incyte Corp. If approved, upadacitinib could help AbbVie lower its reliance on its flagship rheumatoid arthritis drug Humira the world's top...

  • *FDA had rejected a rival JAK inhibitor drug 2 months back. AbbVie's success comes almost two months after the U.S. Food and Drug Administration rejected baricitinib, a rival JAK inhibitor developed by Eli Lilly and Co and Incyte Corp. If approved, upadacitinib could help AbbVie lower its reliance on its flagship rheumatoid arthritis drug Humira the world's top...

  • *Study data comes 2 months after FDA rejection of baricitinib. The late-stage data comes almost two months after the U.S. Food and Drug Administration declined to approve Eli Lilly and Co and partner Incyte Corp's rheumatoid arthritis drug, baricitinib. The FDA has already approved a biosimilar version of Humira, made by Amgen, but AbbVie is trying to block its...

  • May 30- British drugmaker Indivior Plc said on Tuesday it applied for a new drug application to the U.S. Food and Drug Administration to market its drug to treat opioid use disorder. The drug, RBP-6000, is a monthly injectable opioid, used to treat OUD as a part of a treatment plan that includes counseling and psychological support, Indivior said.

  • 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.

  • 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...

  • *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...