FDA


  • 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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    RSV vaccines

    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
  • 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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    FDA sets advisory meeting date for Brainstorm’s ALS cell therapy

    Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

    By June 6, 2023
  • Vials of Eisai and Biogen's new Alzheimer's drug Leqembi
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    Courtesy of Leqembi
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    New Alzheimer's drugs

    Medicare keeps limits on Alzheimer’s drug coverage, but loosens policy

    The agency will reimburse Alzheimer’s treatments like Eisai and Biogen’s Leqembi if they receive full FDA approval, but plans to still require data collection via a patient registry.

    By June 1, 2023
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    Sarah Silbiger via Getty Images
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    FDA clears narrow use of Lynparza in early prostate cancer, continuing ‘shift’ on PARP drugs

    The regulator’s decision to approve the drug only for patients with BRCA mutations ‘increasingly confirms’ the changing perception of PARP blockers, one analyst said.

    By June 1, 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

    Pfizer’s RSV vaccine wins FDA approval in older adults

    The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

    By May 31, 2023
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    Courtesy of Biohaven Ltd.
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    Biohaven sends latest drug to FDA, despite past trial setback

    The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

    By May 31, 2023
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    Grigorii Yalukov via Getty Images
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    Akebia says FDA will give its once-rejected anemia pill a second chance

    The regulator denied an appeal of its decision to turn back vadadustat, but outlined a path forward for the company to resubmit an application without running another clinical trial.

    By May 30, 2023
  • An illustration of the bacteria Acinetobacter baumannii, a common cause of hospital-acquired infections.
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    Dr_Microbe via Getty Images
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    FDA approves new antibiotic for hospital-acquired pneumonia

    The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

    By May 24, 2023
  • A micrograph of a mast cell or mastocyte, with smooth muscle fibers stained in blue.
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    Jose Luis Calvo Martin & Jose Enrique Garcia-Maurino Muzquiz via Getty Images
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    Blueprint wins key FDA approval for rare disease drug

    The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future. But the drug’s sales potential isn’t clear, and a top competitor is close behind.

    By May 23, 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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    FDA approves Krystal gene therapy for rare wound disorder

    Cleared to treat dystrophic epidermolysis bullosa, Vyjuvek is the sixth gene therapy for an inherited disease to gain clearance in the U.S.

    By May 22, 2023
  • 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
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    Future of Intercept’s NASH drug in doubt after FDA panel rejection

    The safety risks of obeticholic acid were too great for an advisory committee to recommend approval without clear proof of its benefits. But collecting that data may not be “economically feasible,” an executive said.

    By Updated May 22, 2023
  • 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
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    RSV vaccines

    FDA advisers back maternal use of Pfizer RSV vaccine

    The panel voted 14-0 that Pfizer’s data showed its shot to be effective. The vaccine could be the first for protecting infants by maternal immunization.

    By May 19, 2023
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    Dr_Microbe via Getty Images
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    FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

    Staff scientists are concerned Intercept Pharmaceuticals’ drug — which could be the first for non-alcoholic steatohepatitis — may cause liver damage and other health problems, documents show.

    By May 17, 2023
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    FDA panel narrowly backs approval of Sarepta’s Duchenne gene therapy

    Shares in Sarepta rose by 25% Monday following a close advisory committee vote supporting accelerated approval of the biotech’s treatment, despite uncertainty around its benefit.

    By , Updated May 12, 2023
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    Courtesy of U.S. Food and Drug Administration
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    FDA advisers back over-the-counter use of birth control pill

    The committee members urged the agency to move quickly to improve access to Perrigo’s contraception pill.

    By Kristin Jensen • May 11, 2023
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    FDA staff skeptical of Sarepta’s Duchenne gene therapy, documents show

    Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

    By Updated May 10, 2023
  • a photo illustration showing packages of Mifepristone tablets
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    Anna Moneymaker/Getty Images via Getty Images
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    Abortion providers in 3 states sue over mifepristone restrictions

    The lawsuit seeks to remove safety restrictions on mifepristone or, alternatively, prevent further altering of access to the drug.

    By Sydney Halleman • May 9, 2023
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    Permission granted by Susan and Chris Finazzo
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    Deep Dive

    ‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA

    FDA advisers voted 8-6 in support of the agency approving a treatment that patient advocates and doctors believe to be a breakthrough for a deadly disease.

    By , May 7, 2023
  • 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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    RSV vaccines

    FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

    The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

    By Updated May 3, 2023
  • A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England.
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    Dan Kitwood via Getty Images
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    FDA clears Pfizer’s pneumococcal vaccine for infants and children

    Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

    By Updated May 3, 2023
  • Seres Therapeutics' microbiome pill Vowst for recurrent C. diff. infections.
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    Courtesy of Seres Therapeutics
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    FDA approves Seres’ microbiota drug for recurrent gut infection

    The drug is the first microbiota-based pill to win U.S. approval. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff. infections.

    By Updated April 27, 2023
  • People gather outside the U.S. Supreme Court in Washington, D.C. on Friday, April 21.
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    Michaela Wong/BioPharma Dive
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    Supreme Court maintains access to abortion pill, blocking restrictions on its use

    The stay suspends a Texas judge’s order that invalidated the FDA’s approval of mifepristone, keeping it available while a circuit court hears the case.

    By Updated April 22, 2023
  • Photomicrograph of a diffuse large B-cell lymphoma (DLBCL) a type of non-Hodgkin lymphoma.
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    iStock / Getty Images Plus via Getty Images
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    FDA approves earlier use of Roche’s Polivy in common form of lymphoma

    The agency’s decision also converts the biologic drug's approval from accelerated to full, confirming an earlier OK based on tumor responses.

    By April 20, 2023
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    Anna Moneymaker/Getty Images via Getty Images
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    Supreme Court delays decision in battle over abortion pill

    An administrative stay of a Texas district court ruling will remain in place through Friday, pushing out a Supreme Court decision in the closely watched case over the drug mifepristone.

    By April 19, 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 favors single dose of updated COVID shots in shift to simplify vaccination

    The regulator also authorized a second bivalent booster for adults 65 years or older, or those with weak immune systems.

    By April 18, 2023