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  • Merck's Welireg and Keytruda combo receives FDA approval for adjuvant kidney cancer therapy
    Merck announced that its combination of the oral VEGFR inhibitor Welireg and the immunotherapy Keytruda has been cleared by the U.S. Food and Drug Administration. The clearance applies to patients…
    Endpoints · 2mo agoApprovalPositive↗ source
  • GSK completes $10.6 billion acquisition of Nuvalent, the largest in its history
    GSK announced it has completed a $10.6 billion purchase of Nuvalent, marking the biggest deal the company has ever undertaken. The transaction was disclosed on Tuesday and values Nuvalent at $124…
    Endpoints · 2mo agoDealNeutral↗ source
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fda recalls67
fda medwatch60
fda press38
1127
Psychiatry & CNS864
Ophthalmology494
Pain478
Endocrinology & Metabolism468
Infectious Disease444
  • Prometheus secures $12 billion to develop artificial general engineers as biotech deals surge
    Prometheus announced a $12 billion capital raise aimed at building what it calls “artificial general engineers,” a new class of AI tools for biopharma research and development. Nonprofit Blood Can…
    STAT · 2mo agoDealPositive↗ source
  • Trump administration proposes rule to close Medicare drug price-negotiation loophole
    The White House announced a proposal to tighten a policy that stops drugmakers from sidestepping Medicare price negotiations by adding new active ingredients to existing products. The change would…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Enliven Therapeutics raises $400M as Jazz's Zepzelca misses confirmatory trial
    Enliven Therapeutics, a biotech based in Burlingame, California, announced that it priced a public offering of its common stock that raised about $400 million. The capital raise follows the compan…
    Endpoints · 2mo agoDealNeutral↗ source
  • Novo's M&A head joins Forbion as Perrigo CEO steps down over conduct concerns
    Novo's senior M&A executive has left the company to take a role at Dutch investment firm Forbion. Forbion, which manages a portfolio of biotech companies, has been active in M&A and aims to increa…
    Endpoints · 2mo agoNeutral↗ source
  • Engaging Religious Leaders Key to Containing Ebola in DRC and Uganda
    An opinion piece by Olivia Wilkinson and Katherine Marshall stresses that Ebola spreads through caring acts such as tending the sick and handling burials, and that mistrust and misinformation often…
    STAT · 2mo agoPositive↗ source
  • Amgen seeks FDA review of Tavneos to determine continued market availability
    Amgen has formally asked the U.S. Food and Drug Administration to re-examine the data supporting its drug Tavneos (avacopan). Tavneos is indicated for a rare form of vasculitis and the request sig…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Eli Lilly backs health-tech startup Abridge to expand clinical trial recruitment
    Eli Lilly’s venture arm has made an investment in Abridge, a health‑technology company that is moving into the clinical trial recruitment space. The funding is intended to help Abridge broaden its…
    Endpoints · 2mo agoDealPositive↗ source
  • Rapport Therapeutics says it is ready to launch its seizure drug independently
    In a recent interview, CEO Abe Ceesay explained that Rapport Therapeutics has assembled an investor syndicate and feels fully prepared to bring its seizure drug to market on its own. Founded in 20…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Veteran researcher warns new OMB grant rule could politicize U.S. science
    David J. Skorton, president of the Association of American Medical Colleges, writes that after four decades in research he has never seen a threat to science like the new grantmaking rule being con…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Hospital finance leaders call for ending billing friction that drives high costs
    At the Healthcare Financial Management Association’s annual meeting in Maryland, hospital finance executives gathered to discuss the persistent problem of affordability in health care. While the hi…
    STAT · 2mo agoNegative↗ source
  • Sciwind Biosciences seeks additional partners for obesity drug ecnoglutide after deals with Pfizer and Verdiva Bio
    Sciwind Biosciences, a Chinese biotech, has licensed its GLP-1 obesity candidate ecnoglutide to two Western companies. The first agreement grants Pfizer rights to develop and commercialize the dru…
    Endpoints · 2mo agoDealPositive↗ source
  • AstronauTx appoints Michelle Mellion as new chief medical officer
    STAT+ columnist Ed Silverman reports on the latest personnel moves in the pharmaceutical sector, a regular feature that tracks hires, promotions and departures. The most recent addition is Michell…
    STAT · 2mo agoPositive↗ source
  • WuXi AppTec Files Lawsuit Against Pentagon Over Chinese Military Designation
    WuXi AppTec, a major contract manufacturing organization in China, has filed a lawsuit in U.S. federal court. The suit challenges the U.S. Department of Defense's decision to place the company on…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • ADA apologizes after expelling five experts for distributing editorial at diabetes conference
    At the American Diabetes Association's annual meeting in New Orleans, five diabetes researchers were expelled and warned they could be arrested after distributing paper copies of an editorial. The…
    STAT · 2mo agoNegative↗ source
  • Blood Cancer United acquires remaining supply of discontinued investigational drug Luvelta
    Blood Cancer United, a nonprofit focused on blood cancers, is purchasing the remaining inventory of Luvelta, an investigational cancer drug that has been discontinued. The acquisition aims to pres…
    STAT · 2mo agoNeutral↗ source
  • Biopharma exec pay reveals quirky perks like private jets and wildfire relief grants
    A recent review of thousands of biopharma C‑suite compensation packages found that most line items blend into the massive totals, but a few stand out for their unusual nature. Among the highlighte…
    Endpoints · 2mo agoNeutral↗ source
  • RFK Jr.’s “Make America Healthy Again” pledge shows mixed progress, tracking successes and gaps
    STAT is monitoring the promises made by Robert F. Kennedy Jr. under his “Make America Healthy Again” agenda, cataloguing which goals have been met, which remain incomplete, and which have not been…
    STAT · 2mo agoNeutral↗ source
  • Chile releases new data on effectiveness of food warning labels
    Chile's health officials have released fresh data that assess how well the country's food warning label system works. The findings add to ongoing research about whether mandatory labels influence…
    STAT · 2mo agoNeutral↗ source
  • Federal probe finds private Medicare Advantage plans deny rehab care, then reverse on appeal
    A federal investigation has revealed that the nation's largest Medicare Advantage insurers routinely deny post-acute rehabilitative services to older and disabled beneficiaries. The review found t…
    STAT · 2mo agoRegulatoryNegative↗ source
  • J&J reports positive Phase 2/3 results for Imaavy in rare autoimmune anemia, paving way for label expansion
    Johnson & Johnson announced that its drug Imaavy, already approved for myasthenia gravis, produced durable hemoglobin improvements in a Phase 2/3 trial for warm autoimmune hemolytic anemia, a rare…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Takeda’s experimental TYK2 inhibitor zasocitinib outperforms Bristol Myers’ Sotyktu in psoriasis trial
    Takeda announced that its experimental TYK2 inhibitor zasocitinib showed statistical superiority over Bristol Myers Squibb’s approved psoriasis drug Sotyktu in a head‑to‑head study. The 16‑week tr…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Actuaries predict continued rise in healthcare costs for next year
    A recent survey of actuaries from 27 health plans that serve both employer groups and individual exchange markets shows early signs of where health-care spending is headed. The respondents expect…
    Endpoints · 2mo agoNegative↗ source
  • Summit Therapeutics cancels $500 million secondary share offering citing market conditions
    Summit Therapeutics announced it would pull a planned $500 million secondary share sale just one day after the announcement, saying market conditions were unfavorable. The offering had been slated…
    BioPharma Dive · 2mo agoDealNegative↗ source