FDA

  • The Bayer logo hangs on the side of a building.
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    Maja Hitij via Getty Images
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    Bayer receives FDA approval for non-hormonal menopause therapy

    Clearance of Lynkuet provides a new alternative to hormone-based treatment for hot flashes and sets up a market battle with Astellas Pharma’s Veozah.

    By • Oct. 27, 2025
  • A sign with the letters GSK hangs on the side of an office building.
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    FDA clears return of GSK’s once-withdrawn multiple myeloma drug

    The new approval completes a surprise turnaround for Blenrep, which was initially cleared in 2020 but pulled from the market only two years later.

    By • Oct. 23, 2025
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    Courtesy of HLTH 2025
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    Top RFK aide lashes out against healthcare industry for profiting off of illness

    Calley Means stopped short of accusing hospitals, insurers and drug companies from actively working to keep Americans sick, but said it was an "economic fact" that the companies benefit financially when people are ill.

    By Susanna Vogel • Oct. 22, 2025
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    Tasos Katopodis via Getty Images
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    Trump administration

    FDA awards 9 companies a new ‘national priority’ voucher to speed drug reviews

    A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine were among the first beneficiaries of a pilot program initiated in June. 

    By • Oct. 17, 2025
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    J&J claims success in study testing earlier Tecvayli use in multiple myeloma

    The result marks a potential advance for dual-targeting antibody drugs like Tecvayli, which are currently relegated to later-line settings for the persistent blood cancer.

    By • Oct. 16, 2025
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    Trump administration moves to fire HHS employees amid shutdown

    “HHS employees across multiple divisions have received reduction-in-force notices,” an administration spokesperson confirmed. It’s a significant escalation of normal shutdown procedures.

    By Rebecca Pifer • Oct. 10, 2025
  • A Regeneron sign in front of a building.
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    Courtesy of Regeneron Pharmaceuticals
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    Regeneron, needing a turnaround, gains new use for cancer drug

    Libtayo’s latest approval for a type of skin cancer should boost future sales, according to one analyst, but doesn’t have the “broad-reaching implications” for Regeneron's Eylea franchise investors had hoped.

    By Kristin Jensen • Oct. 9, 2025
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    Boehringer Ingelheim drug wins FDA OK in tough-to-treat lung disease

    The clearance makes Jascayd the first new drug for idiopathic pulmonary fibrosis in over a decade, but some analysts see it as a “modest” advance in care.

    By • Oct. 8, 2025
  • A photo of FDA CBER Director Peter Marks delivering remarks at a public workshop on March 3, 2020.
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    Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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    Peter Marks, former top FDA vaccine official, joins Eli Lilly

    Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.

    By • Oct. 7, 2025
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    Tasos Katopodis via Getty Images
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    Trump administration

    As shutdown begins, FDA to stop accepting new drug submissions

    The funding lapse triggered by the U.S. government shutdown is the latest test for an agency that’s already dealt with significant layoffs and leadership upheaval this year.

    By Kristin Jensen • Oct. 1, 2025
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    News roundup

    FDA official’s comments spark Aurinia sell-off; Halozyme buys a biotech

    George Tidmarsh criticized Aurinia’s lupus drug in a later-retracted social media post. Elsewhere, the FDA approved a new Novartis drug and two biotechs cut staff.  

    By BioPharma Dive staff • Oct. 1, 2025
  • A white sign with the word Lilly written in red stands outside of an office.
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    Scott Olson via Getty Images
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    Lilly’s oral SERD gets FDA nod in advanced breast cancer

    The clearance of Inluriyo is another development among a group of oral medicines aiming to supplant a widely used, injectable type of hormone therapy.

    By • Sept. 25, 2025
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    Scholar Rock SMA drug rejected by FDA over manufacturing concerns

    The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.

    By • Sept. 23, 2025
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    FDA clears first Barth syndrome drug amid scrutiny of rare disease stance

    After an earlier rejection that drew criticism from some observers, the FDA quickly accepted Stealth BioTherapeutics’ new application and cleared its drug’s use.

    By • Sept. 22, 2025
  • A smiling portrait of Vinay Prasad, the director of CBER, set against a sparkling light background.
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    Retrieved from Vinay Prasad on May 08, 2025
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    Trump administration

    Prasad regains role as FDA’s top doctor, scientist

    An HHS spokesperson confirmed Prasad's reappointment as chief medical and scientific officer, one month after his surprising return to the agency as CBER director.

    By Ned Pagliarulo • Sept. 11, 2025
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    Sarah Silbiger via Getty Images
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    FDA shares guidance to drugmakers developing non-opioid pain medicines

    The agency says it’s open to offering speedy approval pathways for new pain medications that can fight the ongoing opioid addiction crisis.

    By Kristin Jensen • Sept. 11, 2025
  • Image of Johnson & Johnson's Inlexzo, a chemotherapy-eluted implant for treatment of bladder cancer.
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    Courtesy of Johnson & Johnson
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    FDA clears J&J’s drug-device combo for bladder cancer

    J&J executives have said they expect the therapy, Inlexzo, to become a future blockbuster and generate sales that significantly outstrip Wall Street forecasts.

    By • Sept. 10, 2025
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    New Summit data clouds approval pathway in lung cancer

    A combination of ivonescimab and chemo didn’t extend survival over chemo alone in a global trial, missing a key goal often emphasized by regulators.

    By • Sept. 8, 2025
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    FDA outlines new review pathway for drugs treating ultra-rare diseases

    The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect fewer than 1,000 people in the U.S.

    By Ned Pagliarulo • Sept. 4, 2025
  • Boxes of COVID-19 vaccines from Pfizer and Moderna sit side by side.
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    Joe Raedle via Getty Images
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    Vaccines

    FDA approves updated COVID boosters, but narrows use

    While the agency cleared vaccines from Pfizer, Moderna and Novavax broadly in older adults, it restricted eligibility in younger people to those with underlying health conditions.

    By • Updated Aug. 27, 2025
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    Sarah Silbiger via Getty Images
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    Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

    Stealth secured a new agency review of its experimental therapy elamipretide after a rejection this year. The result could carry broader consequences.

    By Alexandra Pecci • Aug. 26, 2025
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    Sarah Silbiger via Getty Images
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    Vaccines

    FDA suspends license for Valneva’s chikungunya shot

    The agency said it had become aware of more reports of serious adverse events, leading center director Vinay Prasad to conclude the vaccine is no longer safe for its intended use.

    By • Aug. 25, 2025
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    Anna Moneymaker via Getty Images
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    FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

    Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.

    By Amy Baxter • Aug. 25, 2025
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    Stealth resubmits rare disease drug to FDA

    The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency’s concerns and now sees potential for a speedy review.

    By • Aug. 18, 2025
  • Two prescription drug cartons stand side by side on a counter, each bearing the word Wegovy.
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    Scott Olson via Getty Images
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    Novo’s Wegovy becomes first GLP-1 drug approved for MASH

    The FDA clearance sets Novo’s medicine up for a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

    By • Aug. 18, 2025