FDA approves first-of-its-kind antibiotic from GSK

The drug is a needed new option for treating uncomplicated UTIs, a common infection that’s becoming harder to treat as rates of microbial resistance rise.

By Delilah Alvarado • March 26, 2025

Alnylam drug gets long-awaited FDA approval in deadly heart disease

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a fast-changing market.

By Ben Fidler • Updated March 20, 2025

FDA sets flu shot recommendations without input of outside advisers

The agency formulated its advice to manufacturers after coordinating with the CDC and Defense Department. An advisory meeting that's typically held was canceled last month.

By Delilah Alvarado • March 14, 2025

Douglas Kelly, deputy science director at FDA’s device center, leaves agency

Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a LinkedIn post Sunday.

By Elise Reuter • March 11, 2025

Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

The Johns Hopkins surgeon highlighted rapid growth at the agency, but pledged key staff will have “all the resources they need to do their job well.”

By Jonathan Gardner • March 6, 2025

Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

Questioned by senators at a Thursday hearing, President Trump's FDA nominee said he would reevaluate which scientific topics require an advisory committee's input.

By Ned Pagliarulo • March 6, 2025

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

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

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

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

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

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

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

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

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

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