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1,783 stories matching this filter · ← front page

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  • AstraZeneca's breast cancer pill camizestrant fails to improve progression-free survival in pivotal SERENA-4 trial
    AstraZeneca announced that its oral estrogen receptor degrader camizestrant, marketed as Etcamah, did not meet its primary endpoint in the phase III SERENA-4 trial. The study evaluated camizestran…
    STAT · 43m agoNegative readoutNegative↗ source
  • FDA approves Isembyld, first therapy to target muscle loss in SMA patients
    Scholar Rock received FDA approval for Isembyld, the first drug designed to address muscle loss in spinal muscular atrophy (SMA). The approval covers adults and children aged two years and older w…
    STAT · 8h agoApprovalPositive↗ source
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fda recalls71
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Endocrinology & Metabolism493
Infectious Disease456
  • Disc sets up polycythemia vera challenge but Silence maintains lead
    The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the…
    BioSpace · 19h agoApprovalPositive↗ source
  • Novartis shares tumble as three late-stage drug candidates fail trials
    Novartis' stock fell more than 13% this week after news that three of its late-stage programs did not meet expectations, pulling down other pharma stocks in the market. The antibody‑oligonucleotid…
    BioSpace · 21h agoNegative↗ source
  • Novartis and Novo Nordisk see back-to-back cardiovascular trial failures, raising doubts for the field
    Novartis announced that its experimental heart‑protective therapy, pelacarsen, did not meet its primary endpoints in a seven‑year study designed to cut heart attacks and strokes by lowering lipopro…
    STAT · 23h agoNegative readoutNegative↗ source
  • Novartis shares tumble 13% after three late-stage drug setbacks hit market
    Novartis' stock dropped more than 13% this week after three of its late-stage programs reported setbacks, pulling down other pharma stocks. The antibody-oligonucleotide conjugate del-desiran faile…
    BioSpace · 21h agoNegative readoutNegative↗ source
  • Novartis board under fire as two late-stage trials fail and CAR-T program paused
    Novartis' board is facing heightened investor scrutiny after the Swiss drugmaker reported failures in two pivotal late-phase trials, raising doubts about its capital deployment strategy for growth…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Cancer drug shortages persist, hampering patient care and highlighting lasting impacts of platinum chemotherapy
    The STAT+ newsletter reports that cancer treatment centers continue to struggle with ongoing shortages of key oncology drugs, forcing clinicians to alter or delay therapy for patients. These short…
    STAT · 18h agoNegative↗ source
  • Samsung Biologics secures $262 million manufacturing contract with European pharma firm
    Samsung Biologics announced a $262 million agreement to provide manufacturing services to an unnamed European pharmaceutical company. The contract runs through 2033. The deal will be executed at S…
    BioSpace · 18h agoDealPositive↗ source
  • Frazier Life Sciences raises over $1.1 billion for its small-mid-cap biotech fund, total commitments now $2.8 billion
    Frazier Life Sciences announced that it has added more than $1.1 billion in new capital to its public fund that targets small and mid‑size biopharma companies. The infusion brings the fund's total…
    BioSpace · 19h agoDealPositive↗ source
  • 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 · 23h 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 · 9h agoRegulatoryPositive↗ 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 · 17h agoNegative↗ source
  • FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissioner
    At the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…
    BioSpace · 1d agoRegulatoryPositive↗ 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 · 15h agoNeutral↗ 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 · 23h 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 · 16h 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 · 20h agoNegative↗ 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 · 16h 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 · 23h agoNeutral↗ source
  • BioSpace to Host Webinar on Using Podcasts, Webinars and Thought Leadership for Pharma Marketing
    BioSpace announced a webinar that will walk PR, communications and marketing teams through the use of podcasts, webinars and thought‑leadership programs to raise executive visibility in biotech and…
    BioSpace · 18h agoNeutral↗ source
  • Whole Foods recalls Cabricharme cheese after undisclosed egg protein found
    Whole Foods Market announced a recall of its Fromagerie Coop de Mean Cabricharme cheese after testing revealed the presence of egg lysozyme, an egg-white protein that was not listed on the label.…
    fda recalls · 9h agoRegulatoryNegative↗ source
  • Encoded Therapeutics secures $275M Series F to advance gene therapy for Dravet syndrome
    Encoded Therapeutics announced a $275 million Series F financing round aimed at moving its lead gene‑therapy candidate, ETX101, toward pivotal trials for Dravet syndrome. In the ongoing Phase 1/2…
    BioSpace · 1d agoDealPositive↗ 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 · 1d agoRegulatoryNegative↗ 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 · 1d agoNegative readoutNegative↗ source