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4,338 stories matching this filter · ← front page

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  • Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead
    Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
    Fierce Biotech · 17h agoApprovalPositive↗ source
  • Senate Health Committee Schedules Vote on FDA Commissioner Nominee Heidi Overton
    Senate health committee set a vote for November 18 on President Trump's nominee Heidi Overton to become FDA commissioner. The outcome will determine whether the nomination proceeds to the full Sen…
    STAT · 3h agoRegulatoryNeutral↗ source
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  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 11h agoDealPositive↗ source
  • Study proposes new obesity metric that could reverse diagnoses for millions, aiming for more precise care
    Researchers published a study in Nature that suggests an alternative way to define obesity could change the diagnosis status for millions of people. The proposed framework separates pre-clinical an…
    STAT · 3h agoNeutral↗ source
  • Flagship Pioneering combines Valo Health and Montai Therapeutics into a single company
    Flagship Pioneering announced that two of its portfolio companies, Valo Health and Montai Therapeutics, are merging to form a new entity. The combined firm will consolidate resources and expertise…
    Endpoints · 3h agoDealNeutral↗ source
  • Incoming Democratic committee chairs move to probe Trump-era most-favored-nation drug pricing deals
    The column notes that the newly appointed Democratic chairs of key congressional committees are planning to examine the most-favored-nation (MFN) drug pricing agreements that were negotiated during…
    STAT · 4h agoRegulatoryNeutral↗ source
  • Beeline Medicines reports promising Phase 2 results for lupus using repurposed Bristol Myers drug
    Beeline Medicines announced that its Phase 2 trial in systemic lupus erythematosus produced encouraging results. The study tested three different doses of a compound originally discovered by Brist…
    Endpoints · 5h agoPositive readoutPositive↗ source
  • VectorY Therapeutics raises $83.5M Series A to develop brain-targeted antibody gene therapy
    VectorY Therapeutics announced it has closed a Series A financing round, adding €74.5 million ($83.5 million) to its capital. The funds will be used to advance its lead gene-therapy candidate VTx-…
    Endpoints · 6h agoDealNeutral↗ source
  • U.S. faces possible loss of measles elimination status as WHO panel convenes
    A WHO regional committee will meet for four days to decide if the United States still meets criteria for measles elimination. Current indicators suggest the country may no longer qualify, raising…
    STAT · 6h agoRegulatoryNegative↗ source
  • Federal panel overseeing preventive care receives blanket ethics waivers despite members' pharma and practice conflicts
    Federal officials granted blanket ethics waivers to every member of the U.S. Preventive Services Task Force, allowing them to serve despite clear financial conflicts of interest. Documents show so…
    STAT · 9h agoRegulatoryNegative↗ source
  • Flagship-backed Valo Health merges with Montai Therapeutics to boost AI-driven drug pipeline
    Valo Health and Montai Therapeutics announced they will combine under the Valo brand, creating a larger AI-focused biotech aimed at accelerating early-stage drug discovery. Valo, launched in 2020…
    Fierce Biotech · 9h agoDealPositive↗ source
  • Merck KGaA receives FDA approval for Abbisko-licensed joint tumor therapy
    Merck KGaA announced that the U.S. Food and Drug Administration has granted approval to a drug it licensed from Chinese biotech Abbisko. The approval covers treatment of rare non-cancerous tumors t…
    Endpoints · 7h agoApprovalPositive↗ source
  • MDCalc unveils CrossCover to boost clinician confidence in AI chatbot answers while protecting privacy
    MDCalc, a medical reference website, announced a new tool called CrossCover. CrossCover is designed to check clinicians' queries for privacy issues and evaluate AI chatbot responses for accuracy,…
    STAT · 9h agoPositive↗ source
  • Capricor cuts 10% of staff as it readies FDA decision on DMD cell therapy, NextCure trims workforce ahead of merger
    Capricor Therapeutics announced that it has reduced its workforce by about 10% during the third quarter, bringing its employee count down from 231 full‑time staff. The company said it had $198.5 mi…
    Fierce Biotech · 14h agoLayoffsNeutral↗ source
  • Amgen builds Sjögren’s case with detailed phase 3 data ahead of Novartis showdown
    Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis.
    Fierce Biotech · 14h agoDealNeutral↗ source
  • Former ER doctor argues that limiting data input can improve clinical AI tools
    Graham Walker, a former emergency‑room physician and co‑founder of MDCalc, was interviewed for STAT’s AI Prognosis newsletter about his new AI tool. Walker explains that giving AI systems only the…
    STAT · 3h agoNeutral↗ source
  • UK science minister urges life-science firms to boost domestic investment as government raises medicine spending
    At a Financial Times Global Pharma and Biotech Summit, the UK science minister highlighted the need for greater domestic investment in life-science companies. The call follows a recent increase in…
    Endpoints · 5h agoPositive↗ source
  • Health-care providers sue employers over out-of-network medical bills
    Providers are increasingly filing lawsuits against employers, arguing that the companies are liable for out-of-network medical charges that insurers have not fully paid or have delayed. One recent…
    STAT · 9h agoRegulatoryNeutral↗ source
  • MAHA backs convicted rapist Russell Brand, highlighting toxic culture within movement
    MAHA Action, the super PAC behind the Make America Healthy Again movement, published a lengthy defense of British comedian Russell Brand after he was sentenced to 10.5 years in prison for rape. Br…
    STAT · 1h agoNegative↗ source
  • Rising food costs and aid cuts leave low-income parents unable to risk nutritious meals for picky eaters
    Rising food prices and cuts to food assistance programs are tightening budgets for low-income families, making fruits and vegetables a less affordable option. When a child refuses a healthy item,…
    STAT · 9h agoNegative↗ source
  • BIO chief warns US biotech must act now to stay ahead of China’s new five-year plan
    John F. Crowley, CEO of the Biotechnology Innovation Organization, says China has unveiled a five-year strategy that labels biotechnology a national pillar industry and aims to overtake the United…
    STAT · 1d agoRegulatoryNegative↗ source
  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Ionis shares tumble over $1 billion as Tryngolza sales forecast cut in half
    Ionis Pharmaceuticals saw its market value drop by more than $1 billion after it lowered its sales outlook for Tryngolza, a triglyceride‑lowering therapy. The company now expects $50 million in sa…
    STAT · 1d agoNegative↗ source
  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 1d agoApprovalPositive↗ source
  • Oura to buy AI health chatbot firm Counsel Health for $625 million
    Oura announced that it will acquire Counsel Health, a startup that builds clinical artificial‑intelligence tools, for a cash price of $625 million. Counsel Health operates a conversational chatbot…
    STAT · 1d agoDealPositive↗ source