FDA: Page 6
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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 -
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 Delilah Alvarado • Feb. 27, 2025 -
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 -
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 Delilah Alvarado • Feb. 24, 2025 -
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 Delilah Alvarado • Feb. 20, 2025 -
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 Jonathan Gardner , Delilah Alvarado • Feb. 20, 2025 -
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 -
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 -
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 Delilah Alvarado , Emily Olsen • Feb. 13, 2025 -
Retrieved from Screenshot: The Food and Drug Administration.
Trump administrationJudge 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 -
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 -
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 Delilah Alvarado • Feb. 10, 2025 -
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 Delilah Alvarado • Feb. 4, 2025 -
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 , Delilah Alvarado , Jonathan Gardner • Updated Feb. 4, 2025 -
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 -
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 Delilah Alvarado • Jan. 29, 2025 -
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 Ben Fidler • Jan. 28, 2025 -
Retrieved from Screenshot: The Food and Drug Administration.
Trump administrationFDA 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 -
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 Delilah Alvarado • Jan. 27, 2025 -
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 -
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 -
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 Jonathan Gardner • Jan. 21, 2025 -
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 -
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 -
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 Delilah Alvarado • Jan. 8, 2025