FDA


  • Loper decision ending Chevron deference doctrine
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    Deep Dive

    FDA’s lab-developed test rule could be first test of agency’s power post-Chevron

    The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

    By Susan Kelly , Elise Reuter • July 11, 2024
  • 5 FDA decisions to watch in the third quarter

    Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.

    By BioPharma Dive staff • July 3, 2024
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    Scott Olson via Getty Images
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    New Alzheimer's drugs

    Lilly drug for Alzheimer’s approved by FDA

    The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

    By Updated July 2, 2024
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    Sarah Silbiger via Getty Images
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    Rocket gene therapy rejected by FDA over manufacturing

    The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

    By June 28, 2024
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    Andrew Harnik via Getty Images
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    Supreme Court overturns Chevron doctrine, limiting reach of federal agencies

    Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

    By Ryan Golden , Ginger Christ • June 28, 2024
  • 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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    Duchenne approval exposes FDA rift over Sarepta gene therapy

    Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

    By June 21, 2024
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    Sarepta Duchenne gene therapy wins broader use from FDA

    The approval makes Elevidys available to most Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness. 

    By Updated June 21, 2024
  • The Merck & Co. sign at the company's building in Summit, New Jersey.
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    Kena Betancur via Getty Images
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    Merck wins FDA OK for vaccine rival to Pfizer’s pneumococcal shot

    The new vaccine, which Merck will sell as Capvaxive, will compete with Pfizer’s blockbuster Prevnar franchise.

    By June 18, 2024
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    Anna Moneymaker via Getty Images
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    Abortion pill ruling offers measure of relief for FDA, biotech

    A biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.

    By June 17, 2024
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    Anna Moneymaker via Getty Images
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    Supreme Court preserves access to abortion pill in unanimous ruling

    The high court said the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA's expansion of mifepristone’s approval.

    By June 13, 2024
  • An illustration of human liver anatomy against a stylized background.
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    Rasi Bhadramani via Getty Images
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    Ipsen drug for rare liver disease approved by FDA

    The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

    By June 11, 2024
  • A U.S. flag flying above a building showing a sign with the word Lilly written in red.
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    Scott Olson via Getty Images
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    New Alzheimer's drugs

    Lilly Alzheimer’s drug gets unanimous backing of FDA panel

    The expert committee's twin 11-0 votes tees up donanemab for U.S. approval later this year and a market showdown with Leqembi.

    By , Updated June 11, 2024
  • Multicolored MDMA pills are seen on a white fabric background in this photo illustration.
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    Makhbubakhon Ismatova via Getty Images
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    After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

    A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

    By June 7, 2024
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    Dr_Microbe via Getty Images
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    New Alzheimer's drugs

    In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

    An advisory panel is meeting today to discuss whether donanemab is effective across different groups of Alzheimer's patients, and to give input on an unusual dosing strategy used by Lilly.

    By June 6, 2024
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    Sarah Silbiger via Getty Images
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    FDA advisers back updating COVID shots to target JN.1 virus family

    The unanimous recommendation from the panel should help Novavax, which would have had difficulty adapting its shot in time if the committee picked a more specific subvariant.

    By June 6, 2024
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    Sarah Silbiger via Getty Images
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    FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

    “I just feel very convinced that I had to vote no,” said one member of the committee, which was unconvinced by Lykos Therapeutics’ data on MDMA-assisted treatment for post-traumatic stress disorder.

    By Updated June 4, 2024
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA staff outline shortcomings of Lykos data for MDMA therapy

    A panel of expert advisers met Tuesday to discuss several sticking points in the clinical trial results backing Lykos’ treatment for PTSD.

    By May 31, 2024
  • A product image of Moderna's RSV shot mRESVIA in its packaged box with syringe in front of the box
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    Permission granted by Moderna
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    RSV vaccines

    Moderna wins FDA approval for RSV vaccine

    The OK for mResvia adds another option for preventing RSV-related disease in older adults, one year after the agency cleared shots from GSK and Pfizer.

    By May 31, 2024
  • 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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    With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals

    But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.

    By May 24, 2024
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    Mario Tama via Getty Images
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    FDA approves Amgen drug for tough-to-treat form of lung cancer

    Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.

    By May 17, 2024
  • The Moderna headquarters is seen on November 30, 2020 in Cambridge, Massachusetts.
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    Maddie Meyer via Getty Images
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    RSV vaccines

    FDA delays decision on Moderna RSV vaccine

    The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

    By May 10, 2024
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    Brillianata via Getty Images
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    Pfizer hemophilia gene therapy arrives in US to uncertain future

    The Food and Drug Administration approval of Beqvez comes as other gene therapies for the bleeding condition struggle to gain traction.

    By April 26, 2024
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA rejects Abeona cell therapy, asks for more manufacturing data

    The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.

    By April 23, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche wins FDA OK for Alecensa in early lung cancer

    Alecensa is the first targeted drug available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.

    By April 19, 2024
  • A photo of Vertex Pharmaceuticals' Boston headquarters.
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    Courtesy of Vertex Pharmaceuticals
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    Vertex begins bid for US approval of non-opioid painkiller

    The biotech has begun a rolling submission of a closely watched drug that’s important to its future, but faces questions of sales potential.

    By April 18, 2024