FDA
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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 a key CDC vaccine panel without change.
By Delilah Alvarado • Feb. 4, 2025 -
Win McNamee via Getty Images
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 12 hours ago -
Elise Reuter/BioPharma Dive
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 -
Win McNamee via Getty Images
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 -
Permission granted by Daiichi Sankyo
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.
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 -
Courtesy of Eisai
New Alzheimer's drugsFDA 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 -
Sarah Silbiger via Getty Images
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 -
Rebecca Noble via Getty Images
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 -
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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 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
RSV vaccinesFDA 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 -
Tracker
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
By Ben Fidler , Delilah Alvarado , Jacob Bell • Jan. 6, 2025 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
Obesity drugsZepbound, 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 -
Sarah Silbiger via Getty Images
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 -
Courtesy of Merck & Co.
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 -
Sarah Silbiger via Getty Images
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 -
Rasi Bhadramani via Getty Images
FDA flags additional injury risk for Intercept’s liver drug
The agency identified 20 cases of serious liver damage associated with Ocaliva in the latest setback for a drug once seen as a potential blockbuster.
By Ben Fidler • Dec. 12, 2024 -
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GLP-1 drug compounding is in limbo. Will the FDA draw out its decision?
The agency is due to make a determination on the shortage status of Zepbound by Dec. 19. But another delay could be possible and, either way, experts predict more litigation.
By Amy Baxter • Dec. 11, 2024 -
Courtesy of UniQure
UniQure shares soar on chance of speedy approval for Huntington’s therapy
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an accelerated approval application.
By Jacob Bell • Dec. 10, 2024 -
Noam Galai via Getty Images
With conflicts of interest in focus, Trump’s pick to run FDA could face scrutiny of his own industry ties
A Johns Hopkins surgeon, Marty Makary also serves as a board member or adviser to several companies, including one that offers compounded GLP-1s.
By Amy Baxter • Dec. 6, 2024 -
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Obesity drugsDiabetes advocacy group discourages use of compounded GLP-1 drugs
The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.
By Jonathan Gardner • Dec. 2, 2024 -
Sarah Silbiger via Getty Images
Applied’s rare disease drug rejected by FDA
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s treatment for classic galactosemia.
By Delilah Alvarado , Ned Pagliarulo • Dec. 2, 2024
