FDA: Page 7
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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 -
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
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 -
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 -
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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 -
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 -
Scott Olson via Getty Images
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 -
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 -
Noam Galai via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Rebecca Noble via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Michael M. Santiago via Getty Images
What RFK Jr.’s influence on Trump could mean for pharma
Past comments by Robert F. Kennedy Jr. hint at the ideas he might advocate if given a role in the incoming Trump administration.
By Amy Baxter • Nov. 8, 2024 -
Chip Somodevilla via Getty Images
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change at the FTC could lower M&A scrutiny.
By Ned Pagliarulo , Ben Fidler • Nov. 7, 2024 -
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Acadia sells speedy drug review voucher for $150M
The selling price is an indication that the FDA’s planned sunsetting of the rare pediatric disease voucher program may be pushing values higher, according to one analyst.
By Kristin Jensen • Nov. 6, 2024 -
Elise Reuter/BioPharma Dive
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on former director Jeff Shuren’s leadership.
By Elise Reuter • Oct. 31, 2024 -
Elise Reuter/BioPharma Dive
FDA names Tarver as new head of device center
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.
By Elise Reuter • Oct. 22, 2024 -
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Novocure wins FDA approval for electric field device in lung cancer
Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.
By Jonathan Gardner • Oct. 16, 2024
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