FDA


  • 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
  • Large letters spelling Amgen are seen by a wall
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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
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    Peddalanka Ramesh Babu via Getty Images
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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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    Christopher Furlong via Getty Images
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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
  • 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 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
  • 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 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
  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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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
  • 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 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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    libre de droit via Getty Images
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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
  • An injection pen containing the drug semaglutide lies on a white plate.
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    Douglas Cliff via Getty Images
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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
  • A Lilly sign is seen on the side of a building viewed through pine trees
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    jetcityimage via Getty Images
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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
  • Exterior of FDA headquarters
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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
  • the FDA Headquarters
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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
  • 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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    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