FDA


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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
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    Courtesy of Sarepta

    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
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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
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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
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    Sarah Silbiger via Getty Images

    Controversial drug for preterm birth to be withdrawn, maker says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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    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
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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
    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
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    Sarah Silbiger via Getty Images

    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
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    Sarah Silbiger via Getty Images
    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
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    Sarah Silbiger via Getty Images

    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
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    Sarah Silbiger via Getty Images

    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
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    Sarah Silbiger via Getty Images

    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
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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
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    Courtesy of GSK

    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
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    Courtesy of U.S. Food and Drug Administration

    FDA offers former biotech unicorn Intarcia a chance for a panel review

    Intarcia, which once held a multibillion-dollar valuation, deflated following the FDA’s 2017 and 2020 rejections of its drug-device combination for diabetes.

    By Feb. 9, 2023
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    FDA approves Gilead’s Trodelvy for expanded use in breast cancer

    The agency’s OK is a win for Gilead, which has bet big on the drug. But the company will face tough competition from AstraZeneca and Daiichi Sankyo’s fast-selling Enhertu.

    By Feb. 3, 2023
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    Courtesy of GSK

    GSK secures FDA approval of anemia drug, but with limitations

    The approval is a win for GSK as the FDA had previously rejected two similar drugs from Akebia Therapeutics and Fibrogen. But it comes with restrictions on its use and a safety warning.

    By Feb. 2, 2023
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    Sarah Silbiger via Getty Images

    FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

    The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

    By Updated Feb. 2, 2023
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    Head of FDA gene therapy office set to retire in March

    Wilson Bryan, a key decision maker in the agency’s oversight of genetic medicines, is expected to leave next month amid an organizational revamp of his office, the FDA confirmed.

    By Kristin Jensen • Feb. 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

    FDA approves cancer drugs from Lilly, Menarini

    The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK.

    By Updated Jan. 31, 2023
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    Merck gets a ‘surprise’ win for Keytruda in early lung cancer

    The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main supporting study, taking one Wall Street analyst by surprise. 

    By Jan. 27, 2023
  • A pharmacist prepares to administer COVID-19 vaccine booster shots on September 09, 2022 in Chicago, Illinois.
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    FDA advisers back agency plan to simplify COVID-19 vaccination

    The expert committee supported making primary and booster shots the same composition, while recommending periodic updates to better match the vaccines to circulating variants.

    By , Updated Jan. 27, 2023
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    Sarah Silbiger via Getty Images

    FDA advisers back Cidara and Melinta’s antifungal treatment

    The drug, if approved, would be the first new treatment in more than a decade for two conditions that stem from Candida fungus.

    By Kristin Jensen • Jan. 25, 2023
  • A pharmacist prepares to administer COVID-19 vaccine booster shots on September 09, 2022 in Chicago, Illinois.
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    FDA weighs shift in COVID vaccination strategy

    Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

    By Jan. 23, 2023