FDA: Page 3

  • FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar

    Eli Lilly’s long-acting copycat drug, first approved in late 2021, now has a designation that will allow pharmacists to swap it for Sanofi’s Lantus.

    By Nov. 18, 2022
  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images

    FDA panel votes in favor of Ardelyx’s once-rejected kidney disease drug

    The recommendation represents a surprising turnaround for Ardelyx’s drug, which the FDA put before an advisory committee only after the biotech appealed its rejection last year.

    By Kristin Jensen • Nov. 17, 2022
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    Jacob Bell

    For ImmunoGen, persistence pays off as FDA clears ovarian cancer drug

    The approval makes Elahere the first wholly owned medicine the biotech has brought to market in its lengthy history.

    By Nov. 15, 2022
  • Colorized scanning electron micrograph of a VERO E6 cell heavily infected with SARS-COV-2 virus particles, isolated from a patient sample.
    Image attribution tooltip
    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Moderna data supports use of omicron booster over original vaccine

    New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.

    By Nov. 14, 2022
  • GlaxoSmithKline CEO Emma Walmsley
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    Courtesy of GSK Flickr page

    Under FDA pressure, GSK limits use of ovarian cancer drug

    The drugmaker’s decision is the latest fallout from safety concerns that have emerged in testing of so-called PARP inhibitors, resulting in withdrawals by Merck & Co., AstraZeneca and Clovis Oncology. 

    By Nov. 11, 2022
  • A photo of Regeneron's Tarrytown, NY headquarters.
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    Regeneron wins broader US use of cancer immunotherapy

    The FDA cleared Libtayo and chemotherapy for use in a broader group of lung cancer patients, a step forward in the company’s plan to compete with rivals Merck and Bristol Myers.

    By Kristin Jensen • Nov. 9, 2022
  • A photo of Sekar Kathiresan, CEO of Verve Therapeutics
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    Seth Babin/BioPharma Dive
    Gene editing

    FDA halts Verve plans to test gene editing therapy for heart disease in US

    Verve didn’t say what led to the FDA’s decision, but claimed it hasn’t observed any safety issues in an ongoing trial in New Zealand and the U.K, where enrollment will continue.

    By Nov. 7, 2022
  • A window with the logo for Amicus Therapeutics.
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    Amicus Therapeutics

    FDA again delays review of Amicus rare disease drug

    For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

    By Oct. 31, 2022
  • Wide shot of a confident Muslim doctor meeting with healthcare professional team.
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    RoosterHD via Getty Images
    Sponsored by Worldwide Clinical Trials

    What the FDA’s guidance on diversity means for rare disease sponsors

    Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

    Oct. 31, 2022
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    ismagilov via Getty Images

    FDA advisers split vote on GSK kidney disease drug, complicating regulatory path

    The anemia pill could become the first drug of its kind to avoid a rejection from U.S. regulators. But an expert panel only supported its use in patients on dialysis, limiting its potential market.

    By Kristin Jensen • Oct. 27, 2022
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    Sarah Silbiger via Getty Images

    Speedy FDA approvals in focus as agency weighs withdrawal of preterm birth drug

    The FDA will soon decide whether to pull Covis’ Makena from the market, more than three years after its confirmatory study failed. The delay highlights the need for reforms to the accelerated approval program, critics say.

    By , Oct. 21, 2022
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Sarah Silbiger via Getty Images

    FDA advisers back withdrawal of controversial drug for preterm birth

    A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.

    By Updated Oct. 19, 2022
  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images

    FDA opens case to withdraw controversial drug for preterm births

    Beginning a high-stakes advisory meeting, CDER head Patrizia Cavazzoni said that Covis Pharma’s drug is ineffective and should not remain on the market.

    By Oct. 17, 2022
  • 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.

    ‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy

    Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference. 

    By Oct. 13, 2022
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    Sarah Silbiger via Getty Images

    Omicron boosters from Pfizer, Moderna cleared by FDA for younger children

    Pfizer's reformulated vaccine is now authorized for use in children at least 5 years of age, while Moderna's will be available for kids as young as 6.

    By Oct. 12, 2022
  • 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 rejects Supernus’ drug infusion device for Parkinson’s

    The company said it will work with the FDA to address issues flagged by the agency in a complete response letter for the apomorphine infusion device.

    By Oct. 10, 2022
  • Obesity drugs

    Lilly looks to speed FDA review of new diabetes drug in obesity

    A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.  

    By Oct. 6, 2022
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images

    FDA clears Roche test for AstraZeneca, Daiichi’s breast cancer drug

    The diagnostic will support rollout of Enhertu, which recently became the first drug for breast tumors with low, but still detectable, levels of the protein HER2. 

    By Nick Paul Taylor • Oct. 5, 2022
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Sarah Silbiger via Getty Images

    5 FDA decisions to watch in the fourth quarter

    The regulator could soon approve medicines from Apellis, Gilead and GSK, and decide whether to pull a controversial preterm birth drug from the market.

    By , , , , Oct. 3, 2022
  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images

    Federal watchdog highlights flaws in speedy FDA approvals

    A newly published report by the HHS inspector general found that a substantial number of drugs given an accelerated approval by the FDA still haven’t proven whether they help patients.

    By Sept. 30, 2022
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    ismagilov via Getty Images

    BioMarin resubmits its hemophilia gene therapy to the FDA

    The resubmission has been long awaited after BioMarin’s original application was unexpectedly rejected by the FDA two years ago. The company expects a decision around the middle of next year.

    By Sept. 30, 2022
  • This image depicts the podcast series page for TD2's BioPharma Dive Podcast series, "Evolution and Innovation in Oncology Therapeutics Development"
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    Anne Callahan/BioPharma Dive
    Sponsored by TD2 Precision Oncology

    [PODCAST] Evolution and Innovation in Oncology Therapeutics Development

    The “Evolution and Innovation in Oncology Therapeutics Development” podcast series explores the role of multi-biomarkers in precision oncology.

    By BioPharma Dive's studioID • Sept. 30, 2022
  • A photograph of Amylyx Pharmaceuticals cofounders Josh Cohen and Justin Klee.
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    Permission granted by Amylyx Pharmaceuticals
    ALS drug development

    ALS drug approved by FDA in closely watched decision, marking win for patients, developer

    The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.

    By Updated Sept. 30, 2022
  • Packaging for a pediatric formulation of Pfizer and BioNTech's COVID-19 vaccine
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    Courtesy of Pfizer

    Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children

    The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating. 

    By Sept. 26, 2022
  • Senators Patty Murray, D-WA and Richard Burr, R-NC, at a meeting of the Senate HELP Committee
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    Joe Raedle / Getty via Getty Images

    FDA user fee package to be included in bill to fund government, avoid shutdown, senators say

    A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.

    By Elise Reuter • Sept. 23, 2022