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1,303 stories matching this filter · ← front page

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  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 7h agoRegulatoryNegative↗ source
  • New evidence links gene‑therapy viral vectors to tumor formation in pediatric patients
    For years, scientists have debated whether the viral vectors used in gene therapy could cause cancer. Recent case reports now provide strong evidence that such a risk is real. The reports involve…
    STAT · 9h agoNegative readoutNegative↗ source
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  • Democrats’ Midterm Wins Boost Hospital Prospects as CVS Breakup Looms
    Voters gave Democrats a decisive edge in the recent midterm elections, reshaping the political landscape for the coming year. The shift is expected to favor the hospital sector, which stands to gai…
    STAT · 5h agoPositive↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 6h agoNeutral↗ source
  • Vir hepatitis D drug succeeds in first pivotal study
    A program that’s survived Vir’s pivot away from infectious disease research hit all of its study objectives and appeared more potent than a rival drug also in late-stage development.
    BioPharma Dive · 6h ago↗ source
  • Recent heart-drug trials miss endpoints, raising doubts about AI-driven drug design
    Two large clinical studies presented at the American Heart Association meeting this weekend failed to show any benefit for experimental heart‑attack and stroke therapies, underscoring the difficult…
    STAT · 1d agoNegative readoutNegative↗ source
  • FDA opens investigation into Novartis' Zolgensma after cancer cases reported
    The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The a…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • Biotech Trade Group BIO Sues Over Medicare GLOBE Pricing Pilot
    BIO and two California biotech trade groups have filed a lawsuit in federal court to stop the Medicare GLOBE pilot that would tie US drug prices to those in peer nations. The complaint argues the…
    STAT · 2d agoRegulatoryNegative↗ source
  • Novo Nordisk’s anti-inflammatory drug ziltivekimab fails to cut heart events, but cardiologists still eye inflammation pathway
    Novo Nordisk reported that its experimental monoclonal antibody ziltivekimab lowered interleukin‑6 levels in the ZEUS trial but did not reduce heart attacks, strokes or cardiovascular deaths compar…
    STAT · 2d agoNegative readoutNegative↗ source
  • STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy
    Medical mystery at the AHA conference: A Novartis drug lowered a risk marker for cardiovascular disease but did not lower chance of heart attack or stroke.
    STAT · 2d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 3d agoApprovalPositive↗ source
  • Novartis reports nine cancer cases in patients treated with Zolgensma gene therapy
    Novartis disclosed that nine individuals with spinal muscular atrophy who received its gene therapy Zolgensma later developed tumors. Two of the cases showed evidence that the adeno-associated vir…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • New evidence links AAV gene therapies to tumor risk, raising safety concerns
    Recent cases reported this year provide strong evidence that adeno-associated viruses (AAVs), the vectors used to deliver therapeutic genes, can trigger tumor formation. The findings settle a two‑d…
    STAT · 3d agoRegulatoryNegative↗ source
  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Immunocore reports early data showing 70% two-year survival with brenetafusp/Kimmtrak combo in uveal melanoma
    Immunocore presented early clinical data on its bispecific T-cell engager combination brenetafusp and Kimmtrak in patients with uveal melanoma. The analysis, based on a subset of patients, indicat…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Amgen’s Repatha linked to fewer heart attacks while Novartis reports seven new tumor cases in Zolgensma patients
    Amgen reported that its cholesterol‑lowering drug Repatha was associated with a lower incidence of heart attacks in a recent analysis. The data suggest the therapy may provide cardiovascular benefi…
    STAT · 3d agoNeutral↗ source
  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 3d agoEarningsPositive↗ source
  • Podcast examines Democrats' midterm win and concerns over a costly, questionable fertility genetic procedure
    Stat's weekly biotech podcast "The Readout LOUD" released an episode featuring Washington correspondent Daniel Payne to discuss how the Democrats' sweeping midterm victory could shape drug pricing…
    STAT · 3d agoNeutral↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy
    Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported. The cases were brought to light by an adv…
    STAT · 4d agoRegulatoryNegative↗ source
  • Revolution Medicines reports $198 million Q3 sales for pancreatic cancer drug Rasonque, calling it best oncology launch ever
    Revolution Medicines' new pancreatic cancer drug Rasonque generated $198 million in revenue in the third quarter, far exceeding analyst expectations of $50‑100 million. The drug received FDA appro…
    BioPharma Dive · 4d agoPositive↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 4d agoApprovalPositive↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source
  • Sickle cell gene-editing therapy shows signs of revival as developers revisit trial after earlier safety halt
    A recent STAT+ article highlights that a sickle cell gene‑editing therapy, whose trial was stopped three years ago after a serious adverse event in the first patient, may be making a comeback. The…
    STAT · 4d agoNeutral↗ source
  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 4d agoNeutral↗ source