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  • Vera Therapeutics receives FDA accelerated approval for Trutakna, an IgA nephropathy drug showing promising kidney function stabilization
    Vera Therapeutics announced that its IgA nephropathy therapy Trutakna has been granted accelerated approval by the U.S. Food and Drug Administration. The approval follows the agency's review of dat…
    BioSpace · 27d agoApprovalPositive↗ source
  • Argenx reports Phase 3 success for Vyvgart Hytrulo in autoimmune myositis, despite subgroup shortfall
    Argenx announced that its subcutaneous antibody Vyvgart Hytrulo achieved its primary endpoint in a Phase 3 trial for autoimmune myositis, a rare group of inflammatory muscle diseases. The trial de…
    Endpoints · 27d agoPositive readoutPositive
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Infectious Disease459
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  • AstraZeneca halts Phase 3 lung cancer trial of volrustomig after negative results
    AstraZeneca announced on Monday that it is ending the Phase 3 study of its lung-cancer drug volrustomig after the trial failed to meet its primary efficacy endpoints. The company said the data did…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Epic faces antitrust lawsuits and internal AI strategy turmoil ahead of annual user meeting
    Epic Systems, founded by Judy Faulkner, dominates the U.S. hospital electronic health record market and convenes its annual User Group Meeting with more than 20,000 attendees. The upcoming gatheri…
    STAT · 27d agoRegulatoryNegative↗ source
  • IRS launches probe into UnitedHealth over alleged tax avoidance from 2017-2020
    UnitedHealth Group is under investigation by the Internal Revenue Service, which says the insurer underpaid taxes by moving money to a foreign subsidiary during 2017-2020. The IRS is seeking to in…
    STAT · 27d agoRegulatoryNegative↗ source
  • Italian biotech sector gains traction as venture capital and tech transfer improvements boost startups
    Italy has long been recognized for its high‑quality scientific research, yet converting that output into successful biotech startups has been a persistent challenge. Recent years have seen a shift…
    BioSpace · 27d agoPositive↗ source
  • Experts say AI could outperform doctors on basic tasks by 2030
    Most clinical AI tools being built today are intended to work under a doctor's supervision. Healthcare and venture-capital experts predict that by 2030 AI may independently perform better than phy…
    Endpoints · 27d agoNeutral↗ source
  • J&J returns rights to lymphoma CAR‑T therapy prizlon‑cel to AbelZeta
    Johnson & Johnson secured exclusive rights to the bispecific CAR T candidate prizlon‑cel in 2023, paying an upfront $245 million. The therapy, designed for large B‑cell lymphoma, achieved a 100% r…
    BioSpace · 27d agoDealNeutral↗ source
  • North Carolina’s bipartisan Medicaid pilot shows social services can cut health costs
    The article, written by former state health secretaries Mandy Cohen and Kody Kinsley, says North Carolina’s health‑care affordability crisis was tackled through a bipartisan pilot. The Healthy Opp…
    STAT · 27d agoPositive↗ source
  • State Laws Cut Private-Equity Acquisitions of Physician Practice Management Firms in Half
    State regulators in more than a dozen states have enacted laws that tighten oversight of private‑equity deals in health care, according to a new report. The tighter rules are reported to be slowing…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Celcuity waits on FDA review of second plant as cancer drug rollout lags expectations
    Celcuity has announced that it is awaiting the U.S. Food and Drug Administration’s review of a second manufacturing facility needed for its newly approved cancer therapy. The company explained tha…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • Trump administration issues executive order overhauling federal vaccine program, drawing WHO criticism
    President Trump signed an executive order on Monday that reshapes the federal vaccine agenda, proposing changes that officials say lack supporting evidence. The World Health Organization publicly…
    STAT · 27d agoRegulatoryNegative↗ source
  • RFK Jr. contrasts vaccine push in D.C. with addiction-treatment focus in California
    In Washington, the health secretary stood beside the president as an executive order was signed to overhaul childhood vaccination policy. The scene highlighted his push for broader vaccine adoption…
    STAT · 27d agoNeutral↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 28d agoRegulatoryNeutral↗ source
  • Becton Dickinson recalls intraosseous needle sets over risk of obturator removal difficulty
    Becton Dickinson has issued a recall for specific intraosseous vascular access system needle sets after discovering that the obturator (stylet) can be difficult to remove once the device is placed.…
    fda medwatch · 28d agoCRLNegative↗ source
  • Oma's Pride recalls one lot of 6 lb Woof Complete canine chicken food after Salmonella contamination
    Oma's Pride of Avon, Connecticut, announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing revealed Salmonella contamination.…
    fda recalls · 27d agoCRLNeutral↗ source
  • Paid paternity leave framed as preventive pediatric care in new opinion piece
    Pediatrician Nishant Pandya shares a recent clinic scene where a new father had to return to work the day after his daughter’s birth, highlighting the tension many families face. He notes that whi…
    STAT · 27d agoPositive↗ source
  • Trump orders MMR vaccine as LSD-targeted drug passes Phase 3 trial
    The latest Endpoints Weekly notes that President Trump placed an order for the measles‑mumps‑rubella (MMR) vaccine. The newsletter also reports that a drug being developed for LSD‑related indicati…
    Endpoints · 29d agoPositive readoutNeutral↗ source
  • FDA approves Bristol Myers' first oral therapy for advanced multiple myeloma, a new drug class
    The U.S. Food and Drug Administration gave its nod to an oral medication from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug represents the first member of a novel clas…
    STAT · 1mo agoApprovalPositive↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 1mo agoApprovalPositive↗ source
  • EU regulator withdraws Amgen's Tavneos authorization over serious trial breaches
    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial. The EMA said study staff from ChemoCent…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 1mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales
    The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…
    BioSpace · 1mo agoApprovalNeutral↗ source
  • FDA grants accelerated approval to Bristol's Zenbexus for multiple myeloma; PBMs adopt TrumpRx pricing; Novartis wins UK Entresto patent
    The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's oral therapy Zenbexus for patients with advanced multiple myeloma. The drug represents a new class of tr…
    STAT · 1mo 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 · 1mo agoRegulatoryPositive↗ source