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4,009 stories matching this filter · ← front page

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  • Kairon Health raises $5M to turn patient data into actionable to‑do lists for value‑based care practices
    Kairon Health, a health‑tech startup, offers a platform that aggregates patient information from claims, electronic health records and pharmacy data and converts it into actionable to‑do lists for…
    Endpoints · 1mo agoDealPositive↗ source
  • 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
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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
  • Danone USA recalls So Delicious Dairy Free Salted Caramel Cluster frozen dessert pints over possible foreign material
    Danone USA announced a voluntary recall of its So Delicious Dairy Free Salted Caramel Cluster non-dairy frozen dessert pints. The recall applies to pints with best‑by dates on or before April 3, 2…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Gias Foods recalls bettergoods Italian Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of two lots of its bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated a potential contamination with Listeria monocytog…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca’s Etcamah fails Phase 3 trial, dashing hopes for $2.9 billion breast cancer market
    AstraZeneca’s oral selective estrogen receptor degrader Etcamah was evaluated in the Phase 3 SERENA-4 trial as a first-line option for patients with ER-positive, HER2-negative advanced breast cance…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA approves Moderna’s mRNA flu vaccine as company reports positive Phase 3 cancer vaccine results
    The FDA has granted approval to Moderna’s mRNA‑based flu vaccine, marking a notable rebound for the technology after the Trump administration cut $500 million in funding for mRNA programs a year ea…
    BioSpace · 1mo agoApprovalPositive↗ source
  • AAM warns that price pressures threaten sustainability of US generics and biosimilars market
    The Association for Accessible Medicines (AAM) issued its annual report warning that the economics of off‑patent drugs have deteriorated, putting the sustainability of the generic and biosimilar ma…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Scholar Rock receives FDA approval for Isembyld, first muscle-targeted SMA therapy
    Scholar Rock announced that its monoclonal antibody apitegromab, branded Isembyld, has been cleared by the FDA for treatment of spinal muscular atrophy (SMA). The approval follows a previous rejec…
    BioSpace · 1mo agoApprovalPositive↗ source
  • BioNTech's CTLA-4 antibody gotistobart shows 8.5-month survival boost in previously treated lung cancer patients
    BioNTech reported new data on its CTLA-4 targeting antibody gotistobart in lung cancer. The study focused on patients whose disease had progressed after prior therapy. Those receiving gotistobart…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • BioNTech's anti-CTLA-4 drug shows survival advantage in advanced squamous lung cancer at WCLC
    BioNTech, together with partner OncoC4, presented new overall survival data at the World Conference on Lung Cancer in South Korea, joining other companies such as Summit Therapeutics, GSK and Roche…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy
    Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition. The approval follows earlier s…
    Endpoints · 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
  • A&P Creations recalls X10 supplement after discovering undeclared Viagra and Cialis ingredients
    A&P Creations LLC announced a voluntary recall of its X10 Natural Enhancement Supplement after testing revealed the presence of sildenafil and tadalafil, the active ingredients in prescription drug…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA seeks external input on rare disease trial criteria and endpoint selection
    The FDA announced it will seek additional external feedback as it reviews how to evaluate efficacy and safety data for rare disease therapies. The agency noted the difficulty of setting appropriat…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • GSK reports 94% response rate for Jideytro in ROS1-positive lung cancer at World Conference
    GSK is moving a newly acquired lung-cancer drug, Jideytro, toward FDA review after presenting data at the World Conference on Lung Cancer. The conference data showed a 94% response rate when Jidey…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Sanofi-backed Electra Therapeutics targets $297 million IPO as Enhertu shows Phase 3 lung cancer success
    Electra Therapeutics, a biotech company supported by Sanofi, announced plans to raise roughly $297 million through an initial public offering. The firm hopes to launch the offering shortly after La…
    Endpoints · 1mo agoDealPositive↗ source
  • Definium's LSD candidate DT120 shows positive Phase 3 results, moving toward FDA submission
    Definium Therapeutics reported positive topline data from its Phase 3 Panorama trial of DT120, an oral LSD formulation for generalized anxiety disorder (GAD). The trial met its primary endpoint, s…
    BioSpace · 1mo agoPositive readoutPositive↗ 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
  • Novo drops Nordisk from name, rebrands as Novo with new bull logo
    Novo Nordisk announced it will drop the "Nordisk" part of its name, rebranding simply as Novo and rotating the iconic Apis bull in its logo to signal a new direction. CEO Mike Maziar Doustdar said…
    BioSpace · 1mo agoNeutral↗ 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
  • AstraZeneca's Etcamah fails late-stage trial for early-stage breast cancer use
    AstraZeneca announced that its newly approved breast cancer therapy, Etcamah, did not meet its primary goals in a pivotal study aimed at expanding the drug's label. The trial evaluated Etcamah in…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Definium Therapeutics reports positive Phase 3 results for oral LSD anxiety drug DT120
    Definium Therapeutics announced Monday that its experimental oral LSD formulation, DT120, achieved positive outcomes in a Phase 3 trial targeting an anxiety disorder. The trial, the company's thir…
    Endpoints · 1mo agoPositive readoutPositive↗ 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