FDA: Page 2


  • Exterior building picture of the Merck KGaA Life Science site in Burlington, U.S.
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    Courtesy of Merck KGaA
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    FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

    Evidence of possible liver damage among study participants adds to growing concerns about the potential of BTK inhibitors to treat MS, a strategy being pursued by several large drugmakers. 

    By Kristin Jensen • April 12, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    Biotech fears ‘dangerous’ precedent as judge challenges FDA authority

    Industry leaders warned that “any medicine is at risk” if a federal judge’s decision to overturn the approval of abortion drug mifepristone is upheld.

    By , April 10, 2023
  • Boxes of mifepristone, the first pill given in a medical abortion
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    Evelyn Hockstein / Reuters

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    Federal judge invalidates FDA approval of abortion pill

    The decision imperils access to the drug more than two decades after its U.S. approval, and could carry consequences for the FDA’s authority over prescription medicines.

    By April 8, 2023
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    Kevin Dietsch via Getty Images
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    FDA withdraws preterm birth drug’s approval, denying maker’s request for delay

    Commissioner Robert Califf and Chief Scientist Namandjé Bumpus determined there was “no justification” for keeping Covis Pharma’s controversial treatment Makena on the market.

    By April 6, 2023
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    del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
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    Gene editing

    Vertex, CRISPR finish US filing for gene editing drug approval

    The approval application is the first in the U.S. for a CRISPR-based medicine and puts the partners ahead of a rival therapy from Bluebird bio. 

    By April 3, 2023
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    5 FDA decisions to watch in the second quarter

    By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy and two vaccines for RSV, as well as issue a precedent-setting decision on a closely watched ALS drug.

    By , , , April 3, 2023
  • Narcan nasal spray bottle and packaging
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    Justin Sullivan via Getty Images
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    FDA approves Narcan for over-the-counter use

    It’s the first time a naloxone-based therapy for opioid overdoses has been cleared for use without a prescription, potentially helping to improve access.

    By March 30, 2023
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    Sarah Silbiger via Getty Images
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    ALS drug development

    BrainStorm files ALS drug application over FDA protest

    The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.

    By March 27, 2023
  • Colonies of Candida albican from a urine sample are seen on a agar media plate.
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    Md Saiful Islam Khan via Getty Images
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    FDA approves new antifungal as concerns grow over drug-resistant fungus

    Rezzayo is the first new treatment for candidemia and invasive candidiasis to win FDA approval in years.

    By Kristin Jensen • March 23, 2023
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Sarah Silbiger via Getty Images
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    ALS drug development

    FDA advisers support conditional clearance of Biogen’s ALS drug

    Though the drug, called tofersen, missed the main goal of a key clinical trial, it showed an effect on a protein tied to ALS. Experts see that as a good sign, but some worry Biogen has not yet gathered enough supportive evidence.

    By March 22, 2023
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    Sarah Silbiger via Getty Images
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    ALS drug development

    FDA staff signal support for Biogen ALS drug, but highlight data hurdles

    In documents released Monday, agency staff appeared inclined to approve Biogen’s tofersen, which failed in its main trial. Gathering confirmatory evidence of its benefit could be difficult, however.

    By , Updated March 20, 2023
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    FDA reversal sets up high-stakes hearing on Sarepta gene therapy

    The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

    By March 17, 2023
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    FDA advisers back earlier use of Roche lymphoma drug

    The positive vote comes despite doubts from FDA scientists and increases the chance that Polivy could soon be approved as a first-line treatment alongside a drug regimen called R-CHOP.    

    By March 10, 2023
  • Pfizer logo
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    Spencer Platt via Getty Images
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    Pfizer’s Biohaven deal pays dividends with new drug approval

    The medicine, a nasal spray for migraines to be sold as Zavzpret, was a key part of Pfizer’s roughly $12 billion buyout of Biohaven last year. 

    By March 10, 2023
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    Controversial drug for preterm birth to be withdrawn, maker says

    The decision by Covis Pharma closes a yearslong battle over continued use of Makena, the only treatment available for prevention of early labor.

    By Updated March 8, 2023
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    Grigorii Yalukov via Getty Images
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    BioMarin, as expected, sees delay to FDA review of hemophilia gene therapy

    The agency is considering three-year follow-up data in its review of Roctavian, pushing back the potential U.S. arrival of BioMarin’s drug once again.

    By Kristin Jensen • March 7, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    Deep Dive

    FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency

    A yearslong regulatory battle over the hormonal shot Makena is approaching its end, with consequences for both preterm birth prevention and the agency’s authority to withdraw drugs shown to be ineffective in follow-up testing.

    By March 6, 2023
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    RSV vaccines

    GSK’s RSV vaccine wins FDA panel backing, matching Pfizer

    Committee members appeared more confident in their recommendation of GSK's shot, with fewer dissents in separate votes on its safety and effectiveness.

    By March 2, 2023
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA asks advisers to review Lynparza amid growing scrutiny of PARP drugs

    The meeting to discuss Lynparza's use as a frontline treatment for prostate cancer follows a string of withdrawals for drugs in its class, and evidence it didn’t meaningfully extend survival in late-stage testing.

    By March 2, 2023
  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images
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    RSV vaccines

    Pfizer’s RSV vaccine gets lukewarm backing of FDA advisers

    The panel voted 7-4 in favor of Pfizer’s shot, but also expressed concerns over its safety profile and what they viewed as holes in the company’s data.

    By March 1, 2023
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA approves Reata rare disease drug in controversial decision

    The clearance, the first for a medicine for Friedreich’s ataxia, comes after years of questions about its benefit and sent the drugmaker’s shares soaring.

    By Kristin Jensen • March 1, 2023
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA rejects Cytokinetics’ heart failure drug

    The biotech said the FDA was unconvinced by available study evidence and asked for data from an additional clinical trial, which the company currently does not plan to run.

    By Feb. 28, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    Billy Dunn, FDA official in charge of neuroscience drug reviews, to leave agency

    Dunn had become a controversial figure after his role in the FDA's review and approval of Biogen's Alzheimer's drug Aduhelm.

    By Updated Feb. 27, 2023
  • A picture of Xavier Becerra giving a speech at a podium
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    Alex Wong via Getty Images
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    CMS plans trio of experiments aimed at lowering drug costs

    The pilot programs could allow adjusted payments for drugs cleared under accelerated approval and help states manage the costs of gene therapies.

    By Feb. 15, 2023
  • A photo of a building showing a GSK sign in London.
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    Courtesy of GSK
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    GSK wins full approval for cancer immunotherapy, looks to expand use

    The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors.

    By Feb. 10, 2023