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  • Swiss biotech Windward Bio raises $175 million in IPO to fund lung-drug development and test Tezspire competitor
    Windward Bio, a Swiss immune‑drug developer, completed a $175 million initial public offering, selling about 10.3 million shares at $17 each. The company began trading on the exchange under the tic…
    BioPharma Dive · 8h agoDealPositive↗ source
  • Virtuoso Surgical receives FDA De Novo clearance for robotic bladder lesion removal system
    Virtuoso Surgical's Virtuoso Endoscopy System received FDA De Novo authorization, marking the first device in a new classification for electromechanical surgical technologies that use robotic instr…
    Fierce Biotech · 6h agoApprovalPositive↗ source
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  • STAT+: Across the U.S., homegrown experiments aim to save kids from their phones
    As researchers struggle to understand phone addiction, young people are finding ways to reclaim their attention and push back against Big Tech.
    STAT · 38m ago↗ source
  • Opinion: STAT+: ‘What will I do with the time I have left?’: What it’s like to find out you might develop Alzheimer’s
    “What people fear isn’t the end of life, the demise of the animated body, but the demise of the mind,” writes Jason Karlawish.
    STAT · 38m ago↗ source
  • 5 takeaways from STAT’s investigation of the sprawling ‘three-parent IVF’ industry
    A STAT investigation of the fertility tourism industry found that clinics are offering an unproven IVF procedure to older women. Here are 5 takeaways from the investigation.
    STAT · 38m ago↗ source
  • STAT+: Oura’s acquisition of health tech startup raises conflict-of-interest questions for Eli Lilly, experts say
    With a new deal announced this week, the relationship between Eli Lilly and a telehealth company that markets GLP-1s is expected to grow more complicated.
    STAT · 38m ago↗ source
  • Senator-elect Abdul El-Sayed on restoring trust in science, the state of public health, and RFK Jr.
    Senator-elect Abdul El-Sayed talks to STAT about restoring trust in science, the state of public health, and RFK Jr.
    STAT · 38m ago↗ source
  • Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial
    Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027.
    Fierce Biotech · 6h ago↗ source
  • Scientists release detailed basal ganglia cell map, uncover new neuron linked to schizophrenia
    Scientists from a large international collaboration have created the most detailed map of the basal ganglia, a brain region that coordinates movement and emotion. The effort profiled over 25 millio…
    STAT · 18h agoPositive↗ source
  • FDA faces over 1,000 vacant positions as staffing shortage strains pharma oversight
    The FDA currently has more than a thousand open jobs, reflecting a deep staffing shortfall that began after a large wave of departures last year. The agency lost 1,343 employees at its CBER and CD…
    BioPharma Dive · 19h agoNegative↗ source
  • Senate debate looms over Heidi Overton’s potential FDA nomination
    The article raises the question of whether Heidi Overton will be nominated to head the FDA and how the Senate might respond. It notes that a committee chair typically schedules a confirmation vote…
    STAT · 18h agoRegulatoryNeutral↗ source
  • New documents spark fresh concerns over Medicare's AI prior-authorization pilot
    New documents have been released that raise additional questions about Medicare's experiment using artificial intelligence to handle prior-authorization requests. The pilot, which seeks to automat…
    STAT · 19h agoRegulatoryNegative↗ source
  • FDA shelves fast-track drug review program launched in 2025
    The U.S. Food and Drug Administration announced it is suspending the fast-track drug review initiative that was introduced in June 2025 under former commissioner Marty Makary. The program, called…
    STAT · 19h agoRegulatoryNegative↗ source
  • American Cancer Society recommends routine PSA screening for men 50-69, strengthens guidance for high-risk groups
    The American Cancer Society (ACS) has updated its prostate-cancer screening guidelines, now advising men at average risk aged 50 to 69 to have a PSA blood test every two years. This replaces the 20…
    STAT · 22h agoRegulatoryPositive↗ source
  • Alnylam faces slowdown in Amvuttra sales, putting its growth ambitions at risk
    Alnylam’s market narrative has long hinged on the performance of its cardiomyopathy drug Amvuttra. The company once hoped the therapy could lift its valuation toward the $100 billion range. Recent…
    STAT · 22h agoNegative↗ source
  • New governors should prioritize health hires, vaccination data, and a focused agenda
    Mandy Cohen and Ellen Montz, former state health leaders, write an opinion piece aimed at the 21 governors who will assume office on Jan. 1. They draw on their experience at the CDC, state health d…
    STAT · 1d agoPositive↗ source
  • BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
    Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
    Fierce Biotech · 1d agoNeutral↗ source
  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA pauses voucher program as Eli Lilly's GLP-1 weight-loss drug cleared in China; experts see AI aid for device regulation
    The U.S. Food and Drug Administration announced it is shelving the commissioner's voucher program, effectively pausing the incentive that speeds up review of certain products. Eli Lilly secured ap…
    raps · 1d agoRegulatoryNeutral↗ source
  • EMA seeks industry input on draft guideline for biomarker-guided therapy approvals
    The European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry for feedback on improving patient-level real-world data submissions
    The FDA announced a request for comments on ways to address challenges associated with submitting patient-level real-world data and evidence in drug and biologic applications. The agency is seekin…
    raps · 1d agoRegulatoryNeutral↗ source
  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 18h agoNeutral↗ source
  • Biogen prepares to unveil results of litifilimab Phase 3 TOPAZ-1 and TOPAZ-2 lupus trials in December
    Biogen is set to release the readout from two pivotal Phase 3 studies, TOPAZ-1 and TOPAZ-2, evaluating its lupus drug litifilimab. The data are expected in the first half of December and will be th…
    STAT · 22h agoPositive readoutNeutral↗ source
  • FDA suspends National Priority Voucher pilot and pauses release of complete response letters
    The Food and Drug Administration has quietly ended the National Priority Voucher pilot, a program that was designed to speed the review of certain drug candidates. In addition, the agency appears…
    Fierce Biotech · 23h agoRegulatoryNeutral↗ source
  • Vor Bio pays RemeGen $10 million for rights to long-acting autoimmune drug candidate RC298
    Vor Bio announced a licensing agreement with RemeGen, paying $10 million upfront in cash and issuing warrants valued at about $46 million for rights to RC298 outside Greater China. RC298 is a long…
    Fierce Biotech · 1d agoDealPositive↗ source