FDA: Page 9
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Trump administrationSara 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 -
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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 -
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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 -
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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 -
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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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Tracker5 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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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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Diabetes 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 -
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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 -
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Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
By Jonathan Gardner , Ned Pagliarulo • Nov. 22, 2024 -
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BridgeBio heart drug approved by FDA, setting up battle with Pfizer
BridgeBio shares climbed by nearly 25% Monday on news its drug for a cardiac form of transthyretin amyloidosis was approved with a broad label that looks competitive to Pfizer's tafamidis.
By Ben Fidler • Nov. 22, 2024 -
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Syndax secures FDA OK for new kind of leukemia drug
Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain pediatric patients with an aggressive form of acute leukemia.
By Delilah Alvarado • Nov. 18, 2024 -
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Trump names RFK Jr. as his pick to lead HHS
The president-elect’s choice of Robert F. Kennedy Jr., a vaccine skeptic who wants to disrupt U.S. health agencies, sent biotech and pharma shares sliding.
By Ned Pagliarulo • Updated Nov. 14, 2024 -
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PTC wins US approval of gene therapy for fatal enzyme disorder
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review voucher for PTC.
By Kristin Jensen • Nov. 14, 2024 -
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AstraZeneca, Daiichi revise approval plans for Enhertu successor
Following mixed study results, the partners have backed away from seeking broad clearance of dato-dxd in lung cancer and instead are aiming for a narrower approval.
By Ben Fidler • Nov. 12, 2024 -
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FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
By Delilah Alvarado • Nov. 11, 2024
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