FDA


  • 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
  • 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 advisers back microbiota-based treatment for gut infection

    Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no approved options after antibiotics fail.

    By Updated Sept. 23, 2022
  • Lilly drug wins FDA clearance for gene-mutated solid tumors, regardless of type

    The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.

    By Kristin Jensen • Sept. 22, 2022
  • A boy with hearing aids and cochlear implants
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    mady70 via Getty Images

    Fennec wins approval of first drug for chemotherapy-induced hearing loss in children

    The drug, Pedmark, has been in development for more than two decades and was previously rejected twice by U.S. regulators. 

    By Sept. 21, 2022
  • A photo of Bluebird bio employees in a laboratory.
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    Courtesy of Bluebird bio

    Bluebird wins FDA approval of gene therapy for rare brain disorder

    The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million per patient. 

    By Updated Sept. 17, 2022
  • Beta-Amyloid Plaques and Tau in the Brain
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

    The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments. 

    By Kristin Jensen • Sept. 15, 2022
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    Danielle Ternes/BioPharma Dive

    BioMarin reports cancer case in hemophilia gene therapy trial

    The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S. Drug regulators have not ordered a trial hold, however.

    By Sept. 13, 2022
  • Exterior sign of Bristol-Myers Squibb
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers gets FDA approval for new type of psoriasis drug

    Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.

    By Updated Sept. 12, 2022
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    Sarah Silbiger via Getty Images
    ALS drug development

    How a top FDA official’s words helped push a closely watched ALS drug toward approval

    Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review. 

    By Sept. 9, 2022
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    FDA names new head to vaccine review office

    David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.

    By Sept. 9, 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
    ALS drug development

    FDA advisers back Amylyx ALS drug, reversing earlier position

    Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.

    By Updated Sept. 7, 2022
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    Getty Images

    FDA holds back Alvotech’s Humira biosimilar over manufacturing issues

    The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.

    By Sept. 6, 2022
  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi

    Sanofi, after long research journey, wins FDA approval for rare disease drug

    Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi.

    By Kristen Jensen • Sept. 1, 2022
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    Sarah Silbiger via Getty Images

    FDA clears updated COVID-19 boosters from Pfizer, Moderna

    The new shots, which are designed to better target circulating strains of omicron, could be available within days.

    By Aug. 31, 2022
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    Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images

    Moderna follows Pfizer in asking FDA to approve updated COVID shot

    The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign.

    By Kristen Jensen • Aug. 24, 2022
  • A worker prepares ampoules of the Nuvaxovid vaccine against Covid-19 by Novavax in Berlin, Germany in February 2022.
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    Carsten Koall via Getty Images

    FDA authorizes Novavax’s COVID-19 vaccine for teens

    The decision will make a third vaccine available for children 12 to 17 years old in the U.S., giving them an option that doesn’t use the messenger RNA technology of shots by Pfizer and Moderna.

    By Updated Aug. 22, 2022
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    Mario Tama via Getty Images

    Pfizer, BioNTech submit omicron booster for FDA clearance

    The revamped shot, which is adapted to the omicron variants now circulating, is key to the Biden administration’s plans for a fall vaccination campaign.

    By Aug. 22, 2022
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    Sarah Silbiger via Getty Images

    Pharvaris studies of rare disease drug put on hold by FDA

    The agency suspended two trials of Pharvaris’ experimental treatment for hereditary angioedema after reviewing nonclinical data, the biotech said.

    By Aug. 22, 2022
  • Neuron
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    koto_feja via Getty Images

    Axsome rebounds to win FDA approval of depression drug

    A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up.

    By Aug. 19, 2022
  • A general view of AstraZeneca is seen during Prime Minister Scott Morrison's visit on August 19, 2020 in Sydney, Australia.
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    Lisa Maree Williams via Getty Images

    New Enhertu approval adds to growing role of well-known cancer target

    AstraZeneca and Daiichi Sankyo’s drug is the first medicine cleared for lung tumors with mutations to HER2, a gene known for its link to breast cancers.

    By Aug. 12, 2022
  • Alexis Borisy and Melanie Nallicheri of EQRx, at launch
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    Courtesy of EQRx

    EQRx, in bid to compete, takes on AstraZeneca’s top seller in head-to-head trial

    The study could be critical for a medicine EQRx plans to position as a competitor to Tagrisso. The drug is under review in the U.K., a first for EQRx.

    By Kristin Jensen • Aug. 11, 2022
  • A medical professional prepares a dose of the monkeypox vaccine on July 23, 2022 in London, England.
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    Hollie Adams via Getty Images

    US takes step to expand monkeypox vaccine supply

    The FDA authorized a new plan that could lead to a five-fold increase in available doses. European health officials may follow the agency's lead. 

    By Kristin Jensen • Aug. 10, 2022
  • Breast Cancer under light microscopy zoom in different areas
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    jxfzsy via Getty Images

    FDA approves AstraZeneca, Daiichi drug in breast cancer first

    Enhertu is the first targeted therapy cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease.

    By Aug. 5, 2022
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    Sarah Silbiger via Getty Images

    Acadia turned back by FDA on second attempt to get psychosis drug approved

    The agency issued Acadia a complete response letter for pimavanserin, for which the company had sought to win an expanded clearance in Alzheimer’s disease psychosis.

    By Aug. 5, 2022