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  • Novo files US and EU approval for etavopivat, its $1B acquired sickle-cell therapy
    Novo submitted regulatory applications in the United States and Europe for etavopivat, a sickle cell disease therapy it bought from Forma Therapeutics in a $1 billion transaction. The company says…
    BioPharma Dive · 1h agoApprovalPositive↗ source
  • Takeda narcolepsy pill receives DEA clearance as Oura-Lilly deal raises conflict concerns and Pfizer exits Canadian Premarin market
    Takeda announced that its experimental narcolepsy medication has been cleared by the U.S. Drug Enforcement Administration, marking the first regulatory nod for a therapy aimed at treating excessive…
    STAT · 1h agoRegulatoryPositive↗ source
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  • Neuroscience startups attract $450M in recent funding, Oyster Therapeutics secures $60M Series A
    Venture capital activity around neuroscience has picked up again, with five neurology-focused startups collectively raising about $450 million in the past few weeks. Data from BioPharma Dive show…
    BioPharma Dive · 1h agoDealPositive↗ source
  • 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 · 14h agoDealPositive↗ source
  • Setbacks in two heart disease trials raise questions about future cardiovascular drug research
    A recent episode of The Readout LOUD highlighted the disappointing results of two high-profile heart disease drugs, noting that both failed to demonstrate benefit in recent studies. The failures w…
    STAT · 2h agoNegative readoutNegative↗ source
  • Oura to acquire telehealth firm Counsel Health, raising conflict-of-interest concerns for Eli Lilly
    Oura, known for its smart rings, announced it will purchase Counsel Health, a telehealth startup that connects patients with clinicians for GLP-1 prescriptions. The acquisition will give Counsel c…
    STAT · 6h agoDealNeutral↗ source
  • Senators propose bill to limit conflicts of interest on preventive services task force
    Two senators, Angus King of Maine and Elizabeth Warren of Massachusetts, announced legislation aimed at tightening conflict‑of‑interest rules for the U.S. Preventive Services Task Force, the panel…
    STAT · 1h agoRegulatoryNeutral↗ source
  • Synchron pauses second-generation brain-computer interface trial, says pause not safety related
    Synchron, a brain-implant startup, announced it is pausing enrollment in its second-generation brain-computer interface trial. Company officials emphasized the decision is operational and not driv…
    STAT · 1h agoNeutral↗ source
  • Investigation reveals U.S. fertility clinics offering unproven three-parent IVF to older women despite safety concerns
    The probe began after a British couple reported that they had paid a U.S.-based firm, International Fertility Group, large sums to travel abroad for an experimental fertility method that is not per…
    STAT · 6h agoNegative↗ source
  • New organ donation rules criticized for pressuring grieving families
    A neurologist at Oregon Health & Science University recounts the case of a 22-year-old woman who was declared brain dead after a traffic accident and became a donor. He describes the intensive moni…
    STAT · 43m agoRegulatoryNegative↗ source
  • Senator-elect Abdul El-Sayed vows to rebuild trust in science amid rising measles and other health threats
    Senator-elect Abdul El‑Sayed is set to become the first epidemiologist to serve in the U.S. Senate, a timing that coincides with a series of public‑health challenges across the country. More than…
    STAT · 6h agoNeutral↗ source
  • New Alzheimer’s biomarker tests raise existential concerns for people without symptoms
    Jason Karlawish, a professor of medicine and neurology at the University of Pennsylvania, reflects on the personal impact of learning one may develop Alzheimer’s before any symptoms appear. He fram…
    STAT · 6h agoNeutral↗ source
  • Local schools launch experiments to curb teen phone addiction
    A teacher in Milwaukee asked her digital journalism class to write about their relationship with devices, uncovering disturbing accounts of constant phone use and online abuse. The students descri…
    STAT · 6h agoNegative↗ 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 · 23h 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 · 1d agoNegative↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 23h agoCRLNegative↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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
  • 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