FDA: Page 2

  • A photo of a Biogen building
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    Permission granted by Biogen
    ALS drug development

    FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

    Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

    By July 26, 2022
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    Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug

    Biogen will try to enforce patents protecting Tysabri, but an executive last week acknowledged that copycat drugs could launch when approved in the U.S.

    By July 25, 2022
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    Sarah Silbiger via Getty Images

    AstraZeneca, Daiichi breast cancer drug set for speedy FDA review

    The agency agreed to quickly assess the companies’ drug Enhertu for “HER2 low” metastatic breast cancer, an indication for which it could become the first targeted treatment option.

    By July 25, 2022
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    Sarah Silbiger via Getty Images

    Novartis, BeiGene cancer drug faces delay as FDA puts off approval decision

    The deferral puts the drug in regulatory limbo, setting back the Swiss pharma's efforts to catch up to top immunotherapy developers Merck, Bristol Myers Squibb and Roche.

    By July 14, 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 clears Novavax's COVID-19 vaccine as 4th option in US

    The shot is the first of its type authorized for COVID-19 by the FDA, but faces an uncertain future due to questions about its ability to fight omicron as well as the biotech’s ability to manufacture large quantities. 

    By Updated July 13, 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, under fire for Aduhelm approval, starts review of another Alzheimer's drug

    The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

    By July 6, 2022
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive

    In 'unusual' move, FDA to reconvene advisers for ALS drug review

    The drug’s developer, Amylyx Pharmaceuticals, said the meeting is scheduled for Sept. 7 and experts will discuss additional data analyses conducted since the last time the panel met.

    By July 5, 2022
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    James Thew/stock.adobe.com

    Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow

    A standard clearance could further broaden Paxlovid’s fast-rising use. But weaknesses are emerging too, among them unclear benefits in vaccinated people and a potential lack of potency against new variants.

    By June 30, 2022
  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi

    FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects

    Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.

    By June 30, 2022
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    Sarah Silbiger via Getty Images

    5 FDA decisions to watch in the third quarter

    Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as a cancer immunotherapy from Novartis. 

    By , , , June 29, 2022
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    Courtesy of Sarepta

    FDA suspends US testing of Sarepta Duchenne drug over safety concerns

    The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.

    By June 23, 2022
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers CAR-T therapy cleared by FDA for earlier lymphoma use

    Breyanzi is now approved in the second-line setting, matching Gilead’s Yescarta, which won a similar clearance from the FDA earlier this year.

    By , June 23, 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 authorizes Pfizer, Moderna COVID-19 vaccines for young children

    The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use.

    By Updated June 19, 2022
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    Sarah Silbiger via Getty Images

    FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

    Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

    By Updated June 15, 2022
  • FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

    The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch. 

    By Kristin Jensen • June 14, 2022
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    Alnylam Pharmaceuticals

    Alnylam wins FDA approval of rare disease drug in step toward profitability

    Amvuttra, a transthyretin amyloidosis medicine previously known as vutrisiran, is viewed by biotech analysts as important to the company’s goal of ending years of financial losses.

    By Updated June 14, 2022
  • Packaging of Pfizer and BioNTech's COVID-19 vaccine in pediatric formulation
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    Courtesy of Pfizer

    FDA staff supportive of Pfizer, Moderna COVID vaccines in young children

    Agency advisers will weigh data from the companies at a two-day meeting that begins Tuesday with discussion of Moderna’s shot in children and teens aged 6 to 17 years old. Use in kids under 5 will be debated Wednesday. 

    By , June 13, 2022
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    Permission granted by Bluebird bio

    FDA advisers offer unanimous support to second Bluebird gene therapy

    By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.

    By Updated June 10, 2022
  • Novavax COVID-19 candidate vaccine NVX-CoV2373 administered to first patients in Phase I Clinical Trial
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    Courtesy of Novavax, Australian Broadcasting Corporation

    FDA advisers back Novavax's latecomer COVID-19 vaccine

    Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made using more traditional technology than Pfizer's and Moderna's.

    By Updated June 7, 2022
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    Sarah Silbiger via Getty Images

    FDA extends review of Amylyx ALS drug, delaying approval decision

    The agency said it wanted more time to assess additional clinical trial data submitted by Amylyx, and set a new decision date of Sept. 29 for the closely watched treatment. 

    By June 3, 2022
  • Packaging for a pediatric formulation of Pfizer and BioNTech's COVID-19 vaccine
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    Courtesy of Pfizer

    Pfizer says 3 doses of its COVID-19 vaccine works in youngest children

    The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

    By May 23, 2022
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    Permission granted by Gilead Sciences

    Gilead, having resolved manufacturing issues, forges ahead with HIV drug

    The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

    By May 17, 2022
  • Lilly wins FDA approval for new kind of diabetes drug

    Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

    By Updated May 16, 2022
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    Sarah Silbiger via Getty Images

    BridgeBio sale of FDA voucher good news for Bluebird, other biotech sellers

    The drugmaker was able to get $110 million for its voucher, a kind of regulatory fast pass. Other vouchers have sold for similar amounts, boding well for Bluebird, which plans to sell two that it hopes to get this year.

    By May 13, 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

    With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

    The proposed changes could have a notable impact on cell and gene therapy developers, many of which are advancing rare disease therapies that rely on speedy approval pathways.

    By May 10, 2022