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

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

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

5 FDA decisions to watch in the fourth quarter of 2025

Against the backdrop of a government shutdown, the agency has a series of critical decisions ahead, among them verdicts on new therapies from Novo Nordisk and Biohaven.

By BioPharma Dive staff • Updated Sept. 30, 2025

FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.

By Ben Fidler • Jan. 2, 2025

Zepbound, Mounjaro shortages are resolved, FDA confirms

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

By Ned Pagliarulo • Dec. 19, 2024

Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year

Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s chief scientist.

By Ned Pagliarulo • Dec. 17, 2024

Merck targets 2025 RSV season with antibody now under FDA review

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

By Delilah Alvarado • Dec. 17, 2024

FDA panel seeks more data on RSV vaccine safety in infants

After several severe RSV cases were reported in a pediatric trial of Moderna's vaccine, the FDA has partially paused testing in young children of certain shots for the virus.

By Delilah Alvarado • Dec. 13, 2024