FDA: Page 2


  • Packaging for Perrigo's over-the-counter birth control Opill
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    Courtesy of Perrigo
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    First nonprescription birth control pill approved by FDA

    The oral contraceptive’s maker, Perrigo, said the pill will be available in drug and grocery stores early next year, but did not disclose its planned price.

    By July 13, 2023
  • Takeda withdraws FDA approval application for dengue vaccine

    While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the U.S. regulator in its current review cycle.

    By July 11, 2023
  • Brain scans of a person with Alzheimer's are seen in this conceptual image.
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    digicomphoto via Getty Images
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    New Alzheimer's drugs

    FDA grants Eisai’s Leqembi full approval, opening door to wider use of Alzheimer’s drug

    In a statement, CMS said it would broaden coverage for the amyloid-targeting therapy and reimburse treatment when patients and physicians participate in a data-collecting registry.

    By Updated July 7, 2023
  • Human respiratory syncytial virus virions are shedding from the surface of human lung cells.
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    National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
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    RSV vaccines

    Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators

    The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

    By Kristin Jensen • July 5, 2023
  • An illustration of red blood cells
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    Brillianata via Getty Images
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    BioMarin finally secures FDA approval of hemophilia gene therapy

    After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

    By June 29, 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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    Ipsen gains FDA panel backing for bone drug acquired in $1.3B buyout

    Despite hesitations, an advisory committee recommended use of the drug — a medicine Roche once developed for lung diseases — to treat the rare condition fibrodysplasia ossificans progressiva. 

    By June 29, 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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    Alvotech to raise cash after third FDA rejection for Humira biosimilar

    The latest regulatory setback, tied to continuing manufacturing issues, ensures Alvotech and partner Teva won’t be able to launch their drug alongside a wave of emerging Humira copycats.  

    By Kristin Jensen • June 29, 2023
  • A photo of Regeneron's Tarrytown, NY headquarters.
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    Regeneron
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    FDA rejection sets back Regeneron’s plan to defend top-selling eye drug

    A manufacturing issue led the agency to turn back an application for a high-dose form of Eylea, surprising analysts and delaying a launch the company is relying on to answer a competitive threat from Roche.  

    By Kristin Jensen • June 28, 2023
  • An illustration of different blood cells types
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    Grigorii Yalukov via Getty Images
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    Pfizer’s hemophilia B gene therapy inches closer to regulatory approval

    The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.

    By June 27, 2023
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images
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    5 FDA decisions to watch in the third quarter

    By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss. 

    By , , June 26, 2023
  • 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.
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    Top FDA official overruled review team in approval of Sarepta’s Duchenne gene therapy

    In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.

    By June 23, 2023
  • A vial of Eisai and Biogen's Alzheimer's disease drug Leqembi
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    Courtesy of Eisai
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    New Alzheimer's drugs

    Medicare has no surprises in planned registry for new Alzheimer’s drugs

    Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.

    By June 23, 2023
  • A micrograph showing triglyceride fat accumulated inside liver cells.
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    Dr_Microbe via Getty Images
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    Intercept to abandon NASH research, lay off staff after FDA drug rejection

    The FDA for the second time turned back Intercept’s application for approval of its drug obeticholic acid in the liver disease, spurring the restructuring.

    By June 23, 2023
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    First Duchenne gene therapy approved by FDA for young children

    The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, but raises the stakes of an ongoing trial that could prove how well it works.

    By Updated June 22, 2023
  • Prostate cancer cells, 3D illustration. Prostate cancer awareness image
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    Dr_Microbe via Getty Images
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    Pfizer’s PARP drug follows Lynparza with narrow clearance in prostate cancer

    As with Merck and AstraZeneca’s medicine, the agency has only cleared Talzenna for use in a subset of newly diagnosed patients who appear most likely to benefit from treatment.

    By June 21, 2023
  • A photo of Bluebird bio signage in a corporate lobby
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    Permission granted by Bluebird bio
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    Bluebird, playing catch-up, gets decision date for sickle cell gene therapy

    The FDA will issue a decision on lovo-cel by Dec. 20, roughly two weeks after a verdict is expected on a rival treatment from Vertex and CRISPR Therapeutics. 

    By Kristin Jensen • June 21, 2023
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    Jonathan Gardner / BioPharma Dive
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    Patient death spurs FDA to pause test of Arcellx’s Gilead-partnered cell therapy

    The company said limitations on “bridging treatment” used to hold cancer in check could be to blame, and is working to change the study’s protocol.

    By June 20, 2023
  • A office building is seen with a sign reading "GlaxoSmithKline."
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    Leon Neal via Getty Images
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    FDA delays decision on GSK bone cancer drug acquired in $2B buyout

    GSK said it remains confident in its application supporting the myelofibrosis medicine momelotinib, which it bought in last year’s deal for Sierra Oncology.

    By June 16, 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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    FDA advisers endorse updating COVID shots to match circulating virus strain

    The expert panel recommended coronavirus vaccines be tailored to target an omicron subvariant known as XBB, which Pfizer, Moderna and Novavax said they’re prepared to do.

    By June 16, 2023
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche follows AbbVie with FDA approval for dual-targeting lymphoma drug

    The approval of Columvi adds another “bispecific antibody” to the market, highlighting progress for drugs that target two proteins rather than one.

    By Updated June 20, 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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    New Alzheimer's drugs

    FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

    In a 6-0 vote Friday, agency advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

    By Updated June 9, 2023
  • A photo of Vertex Pharmaceuticals' Boston headquarters.
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    Courtesy of Vertex Pharmaceuticals
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    Gene editing

    FDA sets decision dates for Vertex, CRISPR gene editing drug

    The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

    By June 9, 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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    FDA advisers back RSV antibody drug for use in infants

    The positive panel vote for AstraZeneca and Sanofi’s treatment is the latest development in a flurry of regulatory activity that’s brought forward new options for preventing RSV-related respiratory disease.

    By June 9, 2023
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive
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    Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi

    Agency advisers are meeting Friday to discuss whether recent trial data confirm Leqembi’s benefit. A vote is expected in the late afternoon. 

    By June 7, 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 staff appear supportive of RSV drug from AstraZeneca, Sanofi

    Agency scientists raised no major red flags in their review of the antibody medicine in documents posted ahead of a Thursday meeting of FDA advisers.

    By June 6, 2023