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4,562 stories matching this filter · ← front page

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  • FDA grants de novo clearance to Powerful Medical’s AI tool for detecting severe heart attacks on EKGs
    The U.S. Food and Drug Administration issued a de novo classification for Powerful Medical’s AI algorithm that analyzes electrocardiograms to identify severe heart attacks. This clearance allows th…
    STAT · 2mo agoRegulatoryPositive↗ source
  • EU Advocate General backs pharma in fight over wastewater treatment cost
    An EU Advocate General has recommended annulling part of a directive that obliges drug and cosmetics makers to fund at least 80% of wastewater treatment costs. The directive, which took effect ear…
    STAT · 2mo agoRegulatoryPositive↗ source
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  • Yarrow Bioscience raises $150M as AbbVie reports positive menstrual migraine trial results
    Yarrow Bioscience, based in New Haven, announced pricing of a $150 million equity offering at $26 per share, roughly $2.50 below the previous closing price. The capital raise will provide addition…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Trade group warns stalled biosimilar development could forfeit billions in savings
    A trade association that represents generic drug makers and biosimilar developers released a new report warning that progress on biosimilar products has slowed. The group says the slowdown threaten…
    Endpoints · 2mo agoNegative↗ source
  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Novartis investors grow wary as drug setbacks spark scrutiny of M&A strategy
    Investors in Novartis are intensifying their examination of the company’s recent dealmaking after a series of setbacks involving drugs that were brought in through mergers and acquisitions. The hei…
    STAT · 2mo agoNegative↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • ALS research pivots to biology-driven biomarkers to capture disease heterogeneity
    ALS drug development is moving beyond traditional measures such as survival time and the ALS Functional Rating Scale. Researchers are now adding biology‑focused approaches that aim to reflect the f…
    Fierce Biotech · 2mo agoPositive↗ source
  • Takeda R&D chief Andy Plump to retire in 2027 as Novo Nordisk names Alex Hoffman global research head
    Takeda announced that its head of research and development, Andy Plump, will step down in June 2027. Plump, who joined Takeda from Sanofi in 2015 and has led R&D since December 2018, will retire af…
    Endpoints · 2mo agoNeutral↗ source
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 2mo agoRegulatoryNegative↗ source
  • U.S. declares end to record cyclospora outbreak linked to iceberg lettuce
    U.S. health officials announced Friday that the nation’s largest cyclospora food‑poisoning outbreak is officially over. The outbreak, which affected 21 states, was tied to contaminated iceberg lett…
    STAT · 2mo agoNeutral↗ source
  • Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
    Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
    Endpoints · 2mo agoDealNeutral↗ source
  • Owkin and Servier partner to use AI platform K Pro for oncology discovery and trial design
    Owkin, an AI drug-discovery CRO, has entered a new agreement with French pharmaceutical company Servier to license its AI scientist, K Pro, for use in Servier’s oncology research and clinical trial…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Pro-vaccine advocates urged to add celebration to messaging after new safety data confirms flu, Covid-19 and RSV shots
    Public‑health communications consultant Adam Zimmerman argues that vaccine advocacy has lost its festive spirit and needs more fun to engage the public. He recalls the 1955 "vaccine party" when th…
    STAT · 2mo agoPositive↗ source
  • CMS guidance lets states use tier system to exempt medically frail Medicaid recipients from work requirements
    The Centers for Medicare and Medicaid Services issued new guidance that permits individual states to apply a tiered approach when deciding which Medicaid enrollees qualify as medically frail and th…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Boycott Targeting American Diabetes Association Expands to Include Medical Journal
    A new boycott has been launched against the American Diabetes Association (ADA). The campaign also calls on a medical journal to join the effort, signaling broader criticism of the organization. T…
    STAT · 2mo agoNegative↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Alloy Therapeutics appoints Venkat Krishnamurthy as chief scientific officer of genetic medicines unit
    Alloy Therapeutics announced the hiring of Venkat Krishnamurthy as chief scientific officer for its genetic medicines division. Krishnamurthy previously held the same role at Flashpoint Therapeuti…
    STAT · 2mo agoNeutral↗ source
  • Thoracic surgeon warns that 9/11 exposure continues to cause lung cancer and mesothelioma decades later
    Raja Flores, a thoracic surgeon at Mount Sinai, treats patients whose illnesses trace back to the dust and fumes of the World Trade Center collapse. He describes how many former first responders an…
    STAT · 2mo agoNeutral↗ source
  • Novartis shareholder urges board overhaul after costly Avidity acquisition setbacks
    Novartis investor David Samra, managing director at Artisan Partners, told Reuters that the company’s board should be reshaped to improve oversight of its dealmaking activities. He said the board n…
    Fierce Biotech · 2mo agoDealNegative↗ source
  • Cancer drug shortages persist at US centers, survey shows many face multiple medication gaps
    An ongoing shortage of cancer medicines is forcing leading US cancer centers to adopt work-around strategies, and a majority say clinical trials have been disrupted, a new survey reports. All cent…
    STAT · 2mo agoRegulatoryNegative↗ source
  • FDA signals openness to innovative trial designs for psychedelic therapies
    FDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • Study finds childhood platinum chemotherapy ages liver cells, may increase future cancer risk
    A new study published in Science examined children who received platinum‑based chemotherapy, such as cisplatin or carboplatin, followed by surgery for hepatoblastoma. Researchers collected samples…
    STAT · 2mo agoNegative readoutNegative↗ source
  • Molecular residual disease testing offers earlier insight into cancer treatment response
    In oncology, determining whether cancer has truly been eliminated after therapy is challenging because imaging and standard clinical criteria often miss low‑level disease. Molecular residual diseas…
    Fierce Biotech · 2mo agoPositive↗ source