FDA


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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
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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 5 hours ago
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    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
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    Why Wall Street shrugged at Lilly’s Alzheimer’s setback

    Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.

    By Jan. 20, 2023
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    FDA lifts hold on Astellas gene therapy for Pompe disease

    The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.

    By Jan. 20, 2023
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    FDA rejects Lilly Alzheimer’s drug, citing insufficient data

    The drugmaker had sought an accelerated approval based on data from a small mid-stage trial. Results from a larger study are due in the second quarter.

    By Jan. 20, 2023
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    JPM23: Califf on accelerated approvals, biotech startups’ looming cliff and an explanation from Editas

    Venture investors cautioned of a coming funding crunch for young biotechs, while the FDA commissioner shared advice for drugmakers.

    By , , Jan. 10, 2023
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    5 FDA decisions to watch in the first quarter

    An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March.

    By , , , Jan. 9, 2023
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    FDA approves drugs from Gilead, Roche, TG Therapeutics to close 2022

    The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.

    By Jan. 3, 2023
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    FDA approval of Biogen Alzheimer’s drug was ‘rife with irregularities,’ congressional report says

    An investigation by two House committees concluded the FDA failed to document all its meetings with Biogen, and shifted to consider an accelerated clearance on a “substantially abbreviated timeline.”

    By Dec. 30, 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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    FDA sets decision date for Alvotech’s Humira biosimilar

    Along with the review deadline, Alvotech also disclosed the FDA had turned back an application for interchangeability as the agency needs to reinspect a manufacturing facility.

    By Dec. 22, 2022
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    Europe broadens Lynparza use as FDA ups scrutiny of PARP drugs

    Lynparza’s authorization in first-line prostate cancer comes days after U.S. regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers.

    By Dec. 21, 2022
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    Government spending bill would tighten FDA oversight of accelerated drug approvals

    The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

    By Dec. 20, 2022
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    Ferring wins FDA approval for bladder cancer gene therapy

    The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.

    By Dec. 19, 2022
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    Another Humira biosimilar approved by FDA as AbbVie patent expiry looms

    Fresenius Kabi is getting ready for a July launch in the U.S. of its copycat version, called Idacio, four years after it began sales in other countries.

    By Kristin Jensen • Dec. 15, 2022
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    Cytokinetics heart drug voted down by FDA panel

    Following years of development, the biotech’s heart failure drug now faces another hurdle in its regulatory path forward, after a group of FDA advisers took issue with its trial evidence. 

    By Dec. 14, 2022
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    Mirati’s KRAS-blocking cancer drug approved by FDA

    Cleared for a certain kind of mutated lung cancer, the medicine will challenge Amgen’s similarly acting treatment Lumakras.

    By Dec. 13, 2022
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    FDA clears updated omicron boosters for youngest children

    Pfizer's reformulated vaccine is now authorized for children 6 months to 4 years of age who have not completed its primary series, while Moderna's updated shot is cleared as a booster for those 6 months to 5 years old.

    By Dec. 9, 2022
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    MEI, Kyowa stop lymphoma drug trials after FDA meeting

    The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

    By Dec. 6, 2022
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    Gene therapy safety

    Verve shares slide after company reveals details on FDA trial hold

    In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks.

    By Dec. 6, 2022
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    Rigel wins US approval of rival drug to Servier leukemia treatment

    The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

    By Dec. 2, 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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    FDA approves first microbiota-based treatment

    The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

    By Dec. 1, 2022
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    Roche pulls Tecentriq in bladder cancer, completing sweep of ‘dangling’ accelerated approvals

    The pharma will no longer market the immunotherapy in the U.S. for urothelial carcinoma, the indication for which the drug was first approved six years ago.

    By Nov. 29, 2022
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    Spectrum to lay off R&D staff after FDA drug rejection

    The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib.

    By Nov. 28, 2022