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72 stories matching this filter · ← front page

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STAT1544Endpoints1211BioSpace552Fierce Biotech548BioPharma Dive461raps189onclive165fda recalls
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allOncology10311Rare Disease2694Immunology2419Cardiology2277Hematology1868Pulmonology1839Vaccines
  • CDC removes pregnancy-specific Covid-19 vaccine guidance page after online backlash
    The CDC briefly posted a webpage that clearly endorsed Covid-19 vaccination for individuals planning to become pregnant. The page was later taken down and now redirects to another section of the C…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • HHS unveils new vaccine injury surveillance plan with NIH clinic and reporting reimbursements
    The Department of Health and Human Services announced a comprehensive initiative to improve monitoring of vaccine-related injuries. The plan includes opening a new clinic at the National Institute…
    BioPharma Dive · 11d agoRegulatoryNeutral↗ source
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Ophthalmology841
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Nephrology633
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 14d agoPositive readoutPositive↗ source
  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 25d agoPositive readoutNeutral↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 25d ago↗ source
  • China unveils new five-year plan to boost biotech and pharma and compete globally
    China's government released its latest five-year plan aimed at expanding the country's biotech and pharmaceutical sectors. The document outlines a strategy to strengthen research, development and m…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Gilead signs HIV PrEP partnership with PAHO in Latin America
    Gilead Sciences announced a new agreement with the Pan American Health Organization to expand access to HIV pre‑exposure prophylaxis across Latin American markets. The partnership aims to leverage…
    Endpoints · 1mo agoDealPositive↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • FDA appoints permanent heads of CDER and CBER, adding AI deputy role
    The Trump administration announced permanent appointments to two key FDA centers after a period of turnover. Michael Davis, who had been acting director of the Center for Drug Evaluation and Resea…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • 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 · 1mo agoPositive readoutPositive↗ source
  • 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 · 1mo agoNegative↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ 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 · 1mo agoPositive readoutPositive↗ source
  • FDA clears updated COVID shots from Pfizer, Moderna and Novavax as Moderna raises $2.6 billion for cancer programs
    The FDA has granted limited approvals for updated versions of three COVID-19 vaccines aimed at the newly dominant XFG variant. The clearances cover Pfizer/BioNTech’s Comirnaty, Moderna’s mNEXSPIKE…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 1mo agoNegative↗ source
  • 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
  • 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
  • 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
  • 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 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
  • 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 · 2mo 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 · 2mo agoNeutral↗ source