FDA


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    FDA approves CAR-T therapies from J&J, Bristol Myers for earlier myeloma use

    The FDA quickly followed last week’s clearance of Bristol Myers’ Abecma with an OK for J&J’s Carvykti, but gave the rival treatments different labels.

    By Updated April 8, 2024
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    Dr_Microbe via Getty Images
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    FDA approves new antibiotic for several hard-to-treat infections

    Swiss pharma Basilea has won clearance for Zevtera after a long development journey, but is still searching for a commercial partner in the U.S.

    By Kristin Jensen • April 4, 2024
  • 5 FDA decisions to watch in the second quarter

    The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

    By BioPharma Dive staff • April 1, 2024
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    AstraZeneca gets FDA OK for rare disease drug acquired in Alexion buyout

    The approval of Voydeya as an add-on therapy for an uncommon blood disease validates a bet Alexion made on original developer Achillion five years ago.

    By April 1, 2024
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    Sarah Silbiger via Getty Images
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    FDA approves Akebia anemia pill, two years after rejection

    The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake. 

    By March 28, 2024
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    Michaela Wong/BioPharma Dive
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    Supreme Court weighs abortion opponents’ standing in mifepristone case

    The high court's treatment of the case, which centers on a conservative challenge to FDA decisions expanding abortion pill access, is seen as potentially consequential for the drug agency. 

    By March 26, 2024
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    Courtesy of Merck & Co.
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    FDA approves Merck lung disease drug acquired in $11B deal

    Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

    By Updated March 27, 2024
  • FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

    The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers. 

    By March 25, 2024
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    Sarah Silbiger via Getty Images
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    FDA clears first-of-its-kind Duchenne drug for broad use

    The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.

    By March 22, 2024
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    Orchard follows buyout with FDA approval of rare disease gene therapy

    The U.S. clearance of Lenmeldy, for a rare and inherited metabolic disease, triggers an additional payout related to Kyowa Kirin’s recent deal to acquire the once high-flying gene therapy developer.  

    By Kristin Jensen • March 19, 2024
  • 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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    FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma

    A majority of experts believed the factors that may have led to an increased risk of early death in testing of Carvykti and Abecma aren’t as likely to occur outside of a clinical trial.

    By March 15, 2024
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    Dr_Microbe via Getty Images
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    Madrigal wins FDA approval of first drug for MASH

    Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

    By March 14, 2024
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    FDA clears use of Novo’s obesity drug to protect heart health

    The approval makes Novo’s Wegovy the first weight-loss drug with such a claim on its prescribing information, which could have important implications for use and insurance coverage. 

    By March 8, 2024
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    FDA delays decision on Lilly’s closely watched Alzheimer’s drug

    The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval. 

    By March 8, 2024
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    Courtesy of U.S. Food and Drug Administration
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    Minerva schizophrenia drug rejected by FDA

    The agency’s complete response letter knocks back Minerva’s attempt to secure approval of the drug over agency reviewers’ objections.

    By Feb. 27, 2024
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    Sara Silbiger via Getty Images
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    Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

    The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S. market.

    By Feb. 26, 2024
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    Sarah Silbiger via Getty Images
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    United Therapeutics, in unusual step, sues FDA over rival’s drug application

    The biotech alleges the agency is letting rival Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.

    By Kristin Jensen • Feb. 21, 2024
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    Stock via Getty Images
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    FDA puts hold on Rapt trials of drug for eczema, asthma

    Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.

    By Feb. 20, 2024
  • Packaging for Iovance Biotherapeutics' cellular medicine Amtagvi is held by a technician wearing gloves.
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    Courtesy of Iovance Biotherapeutics
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    Iovance, with approval of ‘TIL’ cell therapy, readies for complex launch

    The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes. 

    By Feb. 20, 2024
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    Courtesy of Sarepta
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    FDA to review expanded use of Sarepta Duchenne gene therapy

    The agency will decide by June 21 whether to broaden eligibility for Elevidys, and won’t convene a group of outside experts beforehand.

    By Feb. 16, 2024
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    Gilead reviewing drug acquired in $5B buyout after latest setback

    The FDA paused enrollment in the only remaining tests of the drug, as Gilead reviews the program it acquired through a buyout of biotech Forty Seven.

    By Feb. 16, 2024
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    AstraZeneca, Daiichi aim for first pan-tumor ADC approval

    The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.

    By Jan. 29, 2024
  • A photograph of an infusion bag of Abecma, a cell therapy from Bristol Myers Squibb and 2seventy bio
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    Courtesy of Bristol Myers Squibb
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    EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma

    The opinion would allow Abecma to be prescribed after two standard therapies and is the latest sign of CAR-T’s growing use in earlier cancer treatment.

    By Jan. 26, 2024
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    PTC Duchenne drug approval set to be revoked in Europe

    The EMA’s drugs committee again recommended rescinding an OK for Translarna, which was cleared in 2014 despite questions about its benefit.

    By Jan. 26, 2024
  • 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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    At FDA meeting, experts wrestle with hurdles to developing preterm birth drugs

    A workshop highlighted the lack of investment and inadequate understanding of what causes early births, making drug research more challenging.

    By Jan. 25, 2024