FDA: Page 6


  • A CDC sign on the agency's exterior building
    Image attribution tooltip
    Jessica McGowan/Getty Images via Getty Images
    Image attribution tooltip

    The top 3 impacts of Trump’s health data purge

    Interrupted access to the data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.

    By Michael Brady • March 6, 2025
  • A photo of a sign showing the Food and Drug Administration logo
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA meeting on flu vaccine composition is canceled

    The meeting, which helps the FDA give guidance to vaccine makers on which flu strains to target, is the second to be disrupted since Robert F. Kennedy Jr. was sworn in as health secretary.

    By Feb. 27, 2025
  • Food And Drug Administration Headquarters In Maryland
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Trump administration

    FDA brings back some fired device office staff

    An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.

    By Elise Reuter • Feb. 24, 2025
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Mirum drug for rare genetic disease gains FDA approval

    Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with Travere Therapeutics.

    By Feb. 24, 2025
  • A podium showing the logo for the Centers for Disease Control and Prevention is seen.
    Image attribution tooltip
    Kevin C. Cox via Getty Images
    Image attribution tooltip

    CDC vaccine meeting, set to be first since RFK Jr. sworn in, is postponed

    Originally scheduled for next week, the meeting of agency advisers will be delayed to give more time for public comment, an HHS spokesperson said.

    By Feb. 20, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Trump administration

    In FDA job cuts, experts see threat of far-reaching impact

    "Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.

    By , Feb. 20, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Trump administration

    Device industry scrambles amid concern FDA layoffs will cause delays

    Layoffs at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, one attorney said.

    By Elise Reuter • Feb. 20, 2025
  • FDA headquarters sign
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Advamed CEO warns FDA cuts put patients, industry at risk

    Scott Whitaker called for layoffs at the FDA to be reversed, arguing patient care and U.S. leadership in medical devices are on the line.

    By Susan Kelly • Feb. 19, 2025
  • Robert F. Kennedy Jr. sitting with his name printed in front of a microphone in front of him with his arm extended besides him while speaking in a room with government officials in the background.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip
    Trump administration

    RFK Jr. confirmed by Senate as health secretary

    All but one Senate Republican voted for Kennedy, a controversial vaccine critic whose embrace of the “Make America Healthy Again” movement helped him win one of the most powerful jobs in Washington.

    By , Emily Olsen • Feb. 13, 2025
  • Trump administration

    Judge orders FDA, health agencies to restore removed webpages

    District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking healthcare.”

    By Elise Reuter • Feb. 12, 2025
  • A person in a black suit jacket gestures as another listens while seated behind a desk.
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip
    Trump administration

    Trump orders agencies to plan for ‘large-scale’ job cuts

    While Trump’s executive order provides substantial power to Elon Musk’s DOGE effort, it’s not specifically targeted to health agencies like the FDA.

    By Ned Pagliarulo • Feb. 12, 2025
  • An AbbVie sign is seen on the outside of a building in California.
    Image attribution tooltip
    Courtesy of AbbVie
    Image attribution tooltip

    AbbVie, Pfizer gain FDA OK for novel antibiotic

    The drug is cleared to treat complicated intra-abdominal infections, including those caused by tough-to-control, gram-negative bacteria.

    By Feb. 10, 2025
  • Robert F. Kennedy Jr. stands over a desk with his name tag.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip
    Trump administration

    RFK Jr. secured support of key Republican with vaccine pledges

    Sen. Bill Cassidy, whose “yes” vote advanced Kennedy’s nomination as health secretary, said Kennedy promised to maintain ACIP without change.

    By Feb. 4, 2025
  • Robert F. Kennedy Jr. sits behind a desk in a Senate hearing room.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip

    RFK Jr. clears key hurdle on path to become HHS secretary

    Louisiana Sen. Bill Cassidy joined his Republican colleagues in voting to advance Kennedy's nomination to a vote by the full Senate.

    By Sydney Halleman , , Updated Feb. 4, 2025
  • A person sits on a white couch and speaks.
    Image attribution tooltip
    Elise Reuter/BioPharma Dive
    Image attribution tooltip

    Troy Tazbaz, an FDA digital health leader, resigns

    Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial intelligence and software as a medical device.

    By Elise Reuter • Jan. 31, 2025
  • Robert F. Kennedy Jr. speaks while sitting at a desk in a U.S. Senate building.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip

    Democrats clash with RFK Jr. over vaccine views at heated Senate hearing

    Senators challenged Kennedy, who was nominated as health secretary by President Trump, on his long track record of questioning vaccines.

    By Jan. 29, 2025
  • Enhertu
    Image attribution tooltip
    Permission granted by Daiichi Sankyo
    Image attribution tooltip

    Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer

    The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety of tumors.

    By Jan. 28, 2025
  • Trump administration

    FDA webpages on clinical trial diversity removed after Trump orders

    The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, one physician said.

    By Elise Reuter • Jan. 27, 2025
  • Vials of Eisai and Biogen's new Alzheimer's drug Leqembi
    Image attribution tooltip
    Courtesy of Eisai
    Image attribution tooltip
    New Alzheimer's drugs

    FDA clears monthly dosing of Alzheimer’s drug Leqembi

    The approval is the first to come from the FDA since the Trump administration paused external communication by health agencies last week.

    By Jan. 27, 2025
  • Front sign of FDA building
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Trump administration

    Sara Brenner, FDA device official, named agency’s acting head

    Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

    By Elise Reuter • Jan. 24, 2025
  • A person in a business suit speaks at a lectern with a U.S. flag in the background.
    Image attribution tooltip
    Rebecca Noble via Getty Images
    Image attribution tooltip

    Senate sets date to vet RFK Jr.’s nomination to lead HHS

    The Senate Finance Committee will meet on Jan. 29 to discuss the confirmation of RFK Jr., whose stances on vaccines and abortion have raised questions from Democrats and Republicans alike.  

    By Kristin Jensen • Jan. 23, 2025
  • FDA headquarters sign
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer

    The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market opportunity analysts estimate to be worth about $500 million annually. 

    By Jan. 21, 2025
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Federal watchdog cites concerns with FDA’s accelerated approval process

    The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

    By Kristin Jensen • Jan. 15, 2025
  • FDA headquarters with sign in foreground
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Patrizia Cavazzoni, key FDA official, to leave agency

    The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change. 

    By Ned Pagliarulo • Jan. 10, 2025
  • A photo of a sign showing the Food and Drug Administration logo
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Vaccines

    FDA adds warning to RSV shots from GSK, Pfizer

    The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

    By Jan. 8, 2025