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86 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 · 5h 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 · 8h agoPositive readoutPositive↗ source
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fda recalls44
fda medwatch41
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism381
Pain373
Infectious Disease355
  • 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 · 5h agoDealNeutral↗ 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 · 1d 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 · 22h 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 · 1d 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 · 1d 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 · 1d agoRegulatoryPositive↗ 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 · 1d agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Moderna and Merck cancer vaccine returns ‘landmark’ result in melanoma
    At an interim data check, investigators of a key trial found the individualized mRNA treatment kept disease from returning and stopped its spread, sparking a surge in Moderna shares.
    BioPharma Dive · 1d ago↗ 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 · 2d agoRegulatoryNeutral↗ 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 · 3d agoApprovalPositive↗ source
  • Capricor Therapeutics sees stock surge as FDA signals openness to extend review of DMD cell therapy
    Capricor Therapeutics' CEO Linda Marbán told investors that the FDA is receptive to adding open label extension data to its Biologics License Application for deramiocel, its Duchenne muscular dystr…
    BioSpace · 6d agoRegulatoryPositive↗ source
  • FDA grants emergency use authorization for Simparica TRIO to treat New World screwworm in dogs and puppies
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Simparica TRIO, a chewable tablet containing sarolaner, moxidectin and pyrantel, to treat New World screwworm infesta…
    fda press · 7d agoRegulatoryPositive↗ source
  • Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%
    Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Vaccine makers say splitting MMR vaccine is impractical despite presidential directive
    Vaccine manufacturers responded to a recent order from President Donald Trump to separate the combined measles, mumps and rubella (MMR) vaccine, noting that while the concept is theoretically possi…
    Endpoints · 8d agoNeutral↗ source
  • Trump signs executive order to split MMR vaccine and reduce U.S. childhood immunization schedule
    President Donald Trump signed an executive order on Monday that calls for a reduced U.S. childhood vaccine schedule, lowering the number of universally recommended shots from 17 to 11. The order d…
    BioPharma Dive · 9d agoRegulatoryNegative↗ source
  • Austria launches up to €100 million anchor investment for growth fund, aiming to channel half‑billion euros into biotech
    Austria's government announced a new national Startup & Scaleup Fund as part of the 2027/2028 budget, with an anchor investment of up to €100 million. The public money is designed to attract priva…
    BioSpace · 9d agoPositive↗ source
  • Trump orders MMR vaccine to be administered as three separate shots, citing autism concerns
    President Donald Trump announced via an executive order that the combined measles, mumps and rubella (MMR) vaccine should be split into three individual injections for children. He claimed the cha…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • FDA grants emergency use authorization for CLiK Extra wound spray to prevent New World screwworm in livestock and wildlife
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra, a dicyclanil topical suspension designed to be applied around wounds. The authorization allows the pr…
    fda press · 13d agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 14d agoApprovalPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 14d agoApprovalPositive↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 14d agoApprovalPositive↗ source
  • Erica Schwartz confirmed as CDC director after year-long leadership void
    Senate confirmed Erica Schwartz, a public-health veteran and vaccine supporter, as the new head of the CDC. She takes over an agency that has operated without a permanent director for almost a yea…
    BioPharma Dive · 14d agoNeutral↗ source