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  • Windward Bio raises $225 million in IPO to fund Chinese-sourced respiratory drug program
    Windward Bio, backed by Sanofi, completed its initial public offering at the $225 million target, selling 10.3 million shares at $17 each. The proceeds will be used to advance two respiratory drug…
    Fierce Biotech · 9h 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 · 12h agoDealPositive↗ source
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  • 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 · 4h agoDealNeutral↗ 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 · 9h agoApprovalPositive↗ 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 · 4h agoNegative↗ source
  • Gubra appoints ex-HHS official Brett Giroir as co-CEO after sudden exit of Markus Rohrwild
    Gubra, the Danish obesity partner of AbbVie and Boehringer Ingelheim, announced a leadership change following the abrupt departure of its CEO, Markus Rohrwild. The company will operate under a co…
    Endpoints · 1h agoNeutral↗ 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 · 4h 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 · 4h agoNeutral↗ 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 · 10h 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 · 4h 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 · 21h 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 · 23h agoNegative↗ source
  • FDA’s fast-track voucher program appears to be discontinued, report finds
    A recent report indicates that the FDA’s expedited voucher program, launched to speed approval of certain drugs, has not issued any new vouchers in the six months since former commissioner Marty Ma…
    Endpoints · 18h agoRegulatoryNegative↗ 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 · 21h agoCRLNegative↗ source
  • EnGene reports improved bladder cancer data after May setback
    EnGene, a biotech developing a bladder cancer therapy, released new data that appear more encouraging than the results disclosed in May. The May data had shown limited durability, causing a sharp…
    Endpoints · 21h agoPositive readoutPositive↗ source
  • BioNTech spends $205 million to buy Scholar Rock’s FDA priority-review voucher as J&J scales back in Norway
    BioNTech announced it has purchased an FDA priority review voucher from Scholar Rock for $205 million. The voucher, which can be used to accelerate the regulatory review of a future drug, was origi…
    Endpoints · 21h agoDealPositive↗ 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 · 22h agoRegulatoryNeutral↗ source
  • Merck KGaA records €366 million impairment on Lonza CDMO sale as PharmaLogic acquires Lantheus' manufacturing unit
    Merck KGaA disclosed a €366 million ($405.8 million) impairment loss tied to the sale of its contract development and manufacturing organization (CDMO) business to Lonza, according to its third‑qua…
    Endpoints · 22h agoDealNegative↗ 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 · 22h 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 · 23h agoRegulatoryNegative↗ source
  • Parker Institute chief urges renewed focus on cancer immunotherapy after mixed results from Revolution Medicines' drug
    Ira Mellman, who leads research at the Parker Institute for Cancer Immunotherapy, said on Sept. 16, 2026 that he felt disappointment and frustration as the industry celebrated Revolution Medicines'…
    Endpoints · 23h agoNegative↗ 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
  • Blackstone pledges up to $1.5 billion to fund Pfizer's obesity drug berobenatide development
    Blackstone Life Sciences has agreed to provide up to $1.5 billion to support the research and development of Pfizer's obesity candidate, berobenatide, which originated from the former Metsera progr…
    Endpoints · 1d agoDealPositive↗ 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