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71 stories matching this filter · ← front page

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  • Inhibrx reports promising mid-stage data for OX40 agonist and plans vaccine combos early next year
    Inhibrx Biosciences announced that its OX40 agonist showed encouraging activity in a mid-stage trial involving immunogenic cancers. The data suggest the agent may also enhance responses when paire…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 8d agoApprovalPositive↗ source
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Infectious Disease457
  • Funding shortfall threatens progress of new Ebola vaccine candidates
    A rapidly expanding Ebola outbreak in Africa has spurred multiple groups to accelerate vaccine development. The effort is being coordinated by a key global health organization, but the group is fa…
    Endpoints · 8d agoNegative↗ source
  • FDA issues guidance to prevent newborn nutrition supply gap
    The U.S. Food and Drug Administration announced it is taking action to address a potential supply gap of neonatal starter parenteral nutrition, which provides essential IV nutrients to premature an…
    fda press · 8d agoRegulatoryPositive↗ source
  • FDA approves Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 9d agoApprovalPositive↗ source
  • FDA requests public input to accelerate botanical drug product development
    The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward. Botanical drug products are derived from pl…
    fda press · 9d agoRegulatoryNeutral↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 9d agoRegulatoryPositive↗ source
  • GSK to begin Phase 3 trial of mRNA seasonal flu vaccine after strong Phase 2 results
    GSK announced it will start a Phase 3 study of its mRNA vaccine targeting seasonal influenza. The move follows Phase 2 data that showed the candidate produced higher immune responses than traditio…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 14d agoApprovalPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 16d agoApprovalPositive↗ source
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 16d agoRegulatoryPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 17d agoApprovalPositive↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 18d agoApprovalPositive↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 18d agoRegulatoryNeutral↗ source
  • Merck and Moderna report positive topline results for personalized cancer vaccine
    A third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • HHS Secretary RFK Jr. seeks to soften U.S. vaccine recommendations
    HHS Secretary Robert F. Kennedy Jr. has issued a request for information seeking to soften government vaccine recommendations. The request, released on Friday, signals that the administration is s…
    Endpoints · 22d agoRegulatoryNegative↗ source
  • 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 · 23d agoDealNeutral↗ 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 · 23d agoApprovalPositive↗ 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 · 24d 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 · 24d agoRegulatoryPositive↗ 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 · 25d agoRegulatoryNeutral↗ 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 · 1mo agoRegulatoryPositive↗ 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 · 1mo agoNeutral↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 1mo agoRegulatoryNeutral↗ 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 · 1mo agoRegulatoryNegative↗ source