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3,611 stories matching this filter · ← front page

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  • MAHA Summit Shows Grassroots Health Movement Aligning with Industry Leaders
    The recent MAHA Summit brought together federal officials and health‑care executives, marking a shift from the movement’s original grassroots stance. At a panel on affordability, leaders from Unit…
    STAT · 21d agoNegative↗ source
  • SK pharmteco hosts webinar on overcoming ADC linker-payload manufacturing challenges
    SK pharmteco’s European and North American teams presented a webinar that explored the full lifecycle of antibody‑drug conjugate (ADC) linker‑payload development, from facility design to final prod…
    BioSpace · 21d agoNeutral↗ source
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fda medwatch93
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Nephrology645
Study finds blocking T cells entry into brain slows neurodegeneration in mice
Researchers at Washington University in St. Louis reported that preventing certain immune cells, specifically T cells, from entering the brain reduced signs of neurodegeneration in a mouse model.…
STAT · 22d agoPositive↗ source
  • Child health crisis threatens US national security, authors warn
    The authors argue that chronic illness, anxiety, depression and other health problems among children undermine future military readiness, the workforce and the nation’s global competitiveness. The…
    STAT · 22d agoNegative↗ source
  • FDA nominee Heidi Overton’s confirmation won’t be voted on before the midterm elections
    The Senate health committee is set to vote on three HHS leadership nominees on Wednesday, but the nomination for FDA commissioner Heidi Overton is not among them. Overton’s confirmation has been p…
    STAT · 22d agoNeutral↗ source
  • Sociologist finds vaccine-hesitant parents make logical choices, not anti-science
    Jennifer Reich, a sociologist at the University of Colorado, has spent about twenty years interviewing families who choose not to vaccinate their children. Reich, who herself follows the CDC sched…
    STAT · 22d agoNeutral↗ source
  • SNAP cuts risk increasing child separations, advocates warn
    The latest round of SNAP reductions, the biggest in the program’s history, has already left roughly 1.5 million children without food assistance. Studies cited by the authors suggest that losing t…
    STAT · 22d agoNegative↗ source
  • Oura cancels planned IPO citing market uncertainty despite strong demand
    Oura, known for its smart ring, announced it is withdrawing its initial public offering. The company said the decision was driven by ongoing uncertainty in the IPO market, even though it continues…
    Endpoints · 22d agoDealNeutral↗ source
  • STAT+: PhRMA taps Eric Cantor as new CEO
    Eric Cantor, a former GOP House majority leader, is taking the helm of PhRMA at a challenging time for the industry.
    STAT · 22d ago↗ source
  • UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
    The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2…
    BioSpace · 22d ago↗ source
  • Merck pulls Recarbrio antibiotic from U.S. market, raising concerns over superbug resistance
    Merck announced it has stopped supplying Recarbrio in the United States earlier this month. Recarbrio, a three‑drug combination injection approved seven years ago, is used for severe infections su…
    STAT · 22d agoNegative↗ source
  • Kodiak Sciences reports Phase 3 success for Zenkuda, matching Eylea in wet AMD
    Kodiak Sciences announced that its experimental therapy Zenkuda achieved comparable efficacy to the market‑leading anti‑VEGF drug Eylea in a late‑stage trial for wet age‑related macular degeneratio…
    Endpoints · 23d agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 23d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 23d agoDealPositive↗ source
  • Novo Nordisk rebrands GLP-1 therapy Wegovy as weight-loss product, positioning it as lifestyle drug
    GLP-1 drugs have transformed the lives of millions and were originally promoted as medicines for obesity, a medical condition. Recent advertising campaigns are now presenting these drugs as genera…
    STAT · 23d agoNeutral↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 23d agoApprovalNeutral↗ source
  • Rising health insurance premiums and a private equity hospital chain's shift to nonprofit highlight bleak outlook for US healthcare costs
    Bob Herman's latest Health Care Inc. newsletter warns that employer-sponsored health insurance is becoming increasingly unaffordable, with premiums climbing sharply. The piece cites a series called…
    STAT · 23d agoNegative↗ source
  • Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC
    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not…
    BioSpace · 23d agoRegulatoryNegative↗ source
  • Ultragenyx gains FDA approval for Fayuvi, a Sanfilippo syndrome A therapy, easing impact of recent Angelman setback
    Ultragenyx announced that the FDA has approved its drug Fayuvi for treating Sanfilippo syndrome type A, a rare neurodegenerative condition affecting children. The approval marks the company's first…
    BioSpace · 23d agoApprovalPositive↗ source
  • AstraZeneca invests $2 billion for stake in Summit Therapeutics to back its cancer drug
    AstraZeneca announced on Monday that it will invest $2 billion to acquire a minority equity stake in Summit Therapeutics. The investment gives AstraZeneca a slice of the biotech as the companies mo…
    Endpoints · 22d agoDealPositive↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 23d agoRegulatoryNeutral↗ source
  • Merck licenses KRAS G12D inhibitor from Tao Hu for $400 million upfront
    Merck has signed a licensing agreement for a KRAS G12D inhibitor, providing an upfront payment of $400 million. The deal follows a 2023 transaction in which the same entrepreneur, synthetic chemis…
    Endpoints · 23d agoDealNeutral↗ source