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2,485 stories matching this filter · ← front page

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  • States urged to apply tobacco-settlement lessons to Meta’s $18 billion payout
    Susan Morrisey, former head of Colorado’s tobacco‑control coalition, reflects on how the 1998 tobacco settlement was debated and allocated among competing interests in the state. She recalls that…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Experts review five decades of regulatory evolution at RAPS Convergence 2026
    At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • RFK Jr. to keynote Children’s Health Defense event as hospitals criticize GOP rural health fund
    Robert F. Kennedy Jr. is slated to deliver the keynote address at a Children’s Health Defense gathering, marking a return to the anti-vaccine activism that defined his recent public profile. Hospi…
    STAT · 1mo agoNeutral↗ source
  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Judge blocks Trump administration's plan to cap visas for grad students and postdocs
    A federal judge issued a preliminary injunction on Monday, stopping the Trump administration's plan to limit the length of visas used by graduate students and postdoctoral researchers. The Departm…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Abbott to pay $385 million to settle claims over 2022 baby-formula plant shutdown
    Abbott Laboratories agreed to a $385 million settlement related to the 2022 shutdown of its Sturgis, Michigan baby-formula plant, the largest in the United States. The plant’s problems triggered a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Cellectis abandons CAR-T programs, shifts focus to in vivo gene editing
    Cellectis announced it will discontinue its donor-derived CAR‑T programs and redirect its efforts toward in vivo gene‑editing medicines. The company said the commercial and clinical landscape for…
    BioPharma Dive · 1mo agoNegative↗ source
  • GSK presents promising late-stage lung cancer data from two investigational drugs
    GSK highlighted late-stage results for two of its lung cancer candidates, reporting encouraging efficacy signals that could advance the programs toward regulatory review. The company shared the da…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • AstraZeneca's breast cancer drug camizestrant fails pivotal first-line trial
    AstraZeneca announced that its investigational breast cancer drug camizestrant did not meet primary endpoints in a pivotal Phase 3 trial evaluating it as a first-line treatment for advanced disease…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Definium’s LSD therapy cuts anxiety scores in second late-stage trial
    Definium Therapeutics reported that its LSD-based drug DT120 reduced anxiety symptoms in a second late-stage study. In the 12-week trial, patients receiving a 100-microgram dose saw an average 9.8…
    STAT · 1mo agoPositive readoutPositive↗ source
  • FDA appoints new oncology chief, pledges ongoing innovation; approves treatments for two rare genetic disorders
    The Food and Drug Administration has announced a new leader for its Oncology Center of Excellence. The appointee emphasized a continued focus on innovative cancer therapies and collaborative resear…
    raps · 1mo agoRegulatoryPositive↗ source
  • Singapore moves forward with legislation for a more coherent, future-ready healthcare regulatory system
    Singapore's Parliament has taken a step toward overhauling its healthcare regulatory framework by advancing new legislation. The proposed law aims to create a more coherent and future-ready system…
    raps · 1mo agoRegulatoryPositive↗ source
  • Pennsylvania reports third measles death this year, a 40-year-old woman in Jefferson County
    Pennsylvania officials confirmed a third measles-related death in the state this year, involving a 40-year-old woman in Jefferson County. Coroner Greg Furlong said the death was measles-related bu…
    STAT · 1mo agoNegative↗ source
  • Third measles-related death reported in Pennsylvania amid ongoing outbreak
    A 40-year-old woman in Pennsylvania died from complications related to measles, marking the third measles-related fatality in the state in recent weeks. The death was confirmed by Jefferson County…
    STAT · 1mo agoNegative↗ source
  • Novo Nordisk rebrands as "Novo" to signal renewed focus amid slipping market share
    Novo Nordisk announced it will drop "Nordisk" from its name, adopting the shorter brand "Novo" along with a new slogan "Lasting Health Starts Now" as part of a cultural shift. The company says the…
    STAT · 1mo agoNegative↗ source
  • Hospital leaders say GOP's $50 billion rural health fund falls far short of Medicaid cuts
    Republican lawmakers added a $50 billion Rural Health Transformation Fund to the tax‑cut legislation, aiming to help hospitals cope with planned Medicaid cuts. The fund represents only about 5 % o…
    STAT · 1mo agoRegulatoryNegative↗ source
  • EMA says regulators pledge API inspection sharing but report modest progress
    The European Medicines Agency reports that regulators worldwide are strongly committed to sharing plans for good manufacturing practice inspections of active pharmaceutical ingredient suppliers. D…
    raps · 1mo agoRegulatoryNeutral↗ source
  • RAPS Convergence 2026 Highlights Future of Regulatory Science and Patient Safety
    The RAPS Convergence 2026 event gathered regulatory professionals to reflect on how the field has changed. Attendees discussed how emerging technologies are reshaping regulatory processes and expe…
    raps · 1mo agoRegulatoryPositive↗ source
  • Republicans push $500 cash checks for ACA enrollees, highlighting cash-first health policy and GLP-1 drug surge
    Bob Herman’s STAT+ newsletter examines how the Trump administration is issuing $500 checks to a narrow group of Affordable Care Act participants just before the midterm elections. The move reflects…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • EMA issues new guideline on assessing gastrointestinal drug interaction risks
    The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract. The document focuses on extrinsic factors such…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Opinion: Restoring public trust in science requires humility and collaboration, not just better messaging
    Michelle Groman and Caroline Montojo, presidents of The Greenwall Foundation and the Dana Foundation, wrote an opinion piece on Sept. 14, 2026 about the challenge of rebuilding public trust in scie…
    STAT · 1mo agoNeutral↗ source
  • Robert F. Kennedy Jr. to keynote at Children’s Health Defense conference, returning to group he once led
    Health Secretary Robert F. Kennedy Jr. will deliver a keynote address at a conference hosted by Children’s Health Defense, the anti‑vaccine nonprofit he previously led. Kennedy joined the organiza…
    STAT · 1mo agoNeutral↗ source
  • Football fan wrestles with love for the game amid rising CTE concerns
    Michael Arkush, a sportswriter and New York Giants fan, reflects on his excitement for the 2026 season while confronting the growing awareness of chronic traumatic encephalopathy (CTE) in football.…
    STAT · 1mo agoNeutral↗ source