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514 stories matching this filter · ← front page

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  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Merck and Moderna’s melanoma vaccine shows positive Phase 3 results, boosting investor confidence
    Merck and Moderna announced that their personalized melanoma vaccine met the primary endpoint of recurrence‑free survival in a Phase 3 trial when given together with Keytruda. The study showed pati…
    BioSpace · 2mo agoPositive readoutPositive↗ source
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  • Eli Lilly teams with Amplitude on taRNA vaccine platform as Otsuka ends psychedelic trial
    Eli Lilly announced a collaboration with Amplitude Therapeutics to co‑develop vaccine candidates using a trans‑amplifying RNA (taRNA) platform. The taRNA approach aims to boost antigen expression…
    Endpoints · 2mo agoDealNeutral↗ source
  • Medigen partners with Charles River to advance multivalent enterovirus vaccine globally
    Charles River Laboratories and Taiwan's Medigen Vaccine Biologics announced a collaboration to prepare Medigen’s multivalent enterovirus vaccine for worldwide use. The partnership will focus on ch…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • American Cancer Society cancels wine and spirits gala amid conflict-of-interest concerns
    The American Cancer Society announced it will not hold the planned Wine and Spirits Industry Gala after internal review highlighted a conflict of interest with the alcohol sector, which is linked t…
    STAT · 2mo agoNeutral↗ source
  • Merck and Moderna report success in late-stage trial of personalized mRNA cancer vaccine
    Merck and Moderna announced that their personalized mRNA cancer vaccine achieved its primary endpoint in a randomized late-stage trial, marking the first demonstration that such an approach can be…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Moderna shares surge as Merck-Moderna mRNA melanoma vaccine meets Phase 3 endpoint
    Merck and Moderna reported that their personalized mRNA cancer vaccine, combined with Merck’s Keytruda, slowed melanoma recurrence in a Phase 3 study. The interim analysis showed a statistically si…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Merck and Moderna report personalized mRNA vaccine delays melanoma recurrence in late-stage trial
    Merck and Moderna announced that a personalized mRNA cancer vaccine, when combined with standard therapy, slowed the return of melanoma and reduced its spread in a late-stage clinical study. The tr…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Moderna and Merck report success for personalized mRNA vaccine in late-stage melanoma trial
    Moderna and Merck announced that their personalized mRNA cancer vaccine succeeded in a late-stage melanoma study. The vaccine, called intismeran, was evaluated in a randomized Phase 3 trial, the fi…
    STAT · 2mo agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 2mo agoApprovalPositive↗ source
  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Moderna cancer vaccine data lifts investor confidence, shares jump to multi-year highs
    Moderna has long said it wants to broaden its portfolio beyond infectious-disease vaccines. The company has been working on a cancer vaccine and investors have been waiting for late-stage trial res…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 2mo agoRegulatoryPositive↗ source
  • Trump administration expected to nominate White House policy aide Heidi Overton as FDA commissioner
    President Donald Trump is expected to put forward White House deputy director of domestic policy Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to STAT.…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump is reported to be selecting Deputy Director of the White House Domestic Policy Council Heidi Overton, a physician, to be the next FDA commissioner, pending Senate confirmatio…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Immunologist Liz Marnik, raised unvaccinated, now advocates for science and empathy in vaccine discussions
    Immunologist Liz Marnik grew up in a household that rejected vaccines, and she herself went without any immunizations into adulthood. At age 23 she visited a travel clinic and received all standar…
    STAT · 2mo agoPositive↗ source
  • Merck and Moderna’s personalized mRNA vaccine shows longer recurrence-free survival in phase 3 melanoma trial
    Merck and Moderna reported that their individualized mRNA cancer vaccine, given together with Keytruda, extended the time patients remained free of melanoma recurrence in a late-stage study. The p…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Academic groups sue DHS over new four-year visa limit for foreign graduate students and postdocs
    Groups representing universities and educators filed a lawsuit in U.S. District Court in Massachusetts against the Department of Homeland Security. The suit challenges a new DHS rule that would re…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA releases discussion paper seeking input on regulation of generative AI medical devices
    The U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
    fda press · 2mo agoRegulatoryNeutral↗ source
  • Study shows antibiotic overuse is concentrated in high-income nations, while low-income countries struggle with shortages
    Peter Beyer, deputy executive director of the Global Antibiotic Research & Development Partnership, writes an opinion piece highlighting a shift in how antimicrobial resistance is framed across the…
    STAT · 2mo agoNeutral↗ source
  • Kindergarten vaccine exemptions rise as Doritos marketing sparks food-health debate
    A recent Morning Rounds briefing highlighted that exemptions for childhood vaccines are increasing in kindergarten classrooms, raising concerns among public health observers. The same report also…
    STAT · 2mo agoNeutral↗ source
  • Opinion warns US surrogacy system is chaotic and may face bans after decades of legal battles
    Arthur Caplan writes that the United States surrogacy framework is poorly managed, using the recent West case as a warning sign. He argues that the lack of clear rules could lead to broader bans.…
    STAT · 2mo agoNegative↗ source
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 2mo agoApprovalPositive↗ source