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493 stories matching this filter · ← front page

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  • Supreme Court rules generic Vascepa copy does not infringe patents, boosting skinny-label pathway
    The U.S. Supreme Court issued a decision that Hikma Pharmaceuticals’ generic version of Amarin’s heart drug Vascepa does not infringe the brand’s patents. The ruling clarified that the generic make…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • ADC Therapeutics shares plunge as Phase 3 trial of Zynlonta shows high death rate despite efficacy gain
    ADC Therapeutics reported Phase 3 data for Zynlonta combined with rituximab in a hard-to-treat blood cancer. The trial met its primary endpoint by extending progression-free survival versus standar…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
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fda recalls67
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Infectious Disease439
  • Grail’s Galleri multi-cancer early detection trial misses primary endpoint, but oncologists note promising signals
    The first randomized trial of a multi-cancer early detection test enrolled about 143,000 English adults aged 50 to 77. Participants were randomly assigned to receive either standard care or the Gal…
    STAT · 3mo agoNegative readoutNeutral↗ source
  • Lawmakers backtrack on promised Medicaid protections for cancer patients, new CMS rules impose work requirements
    Gwen Nichols, a hematologist/oncologist and chief medical officer of Blood Cancer United, wrote that lawmakers who pledged to protect cancer patients from Medicaid cuts are now backing a policy tha…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Otsuka's Voyxact reduces kidney function decline in IgA nephropathy but falls short of expectations in Phase 3
    Otsuka reported Phase 3 trial results for its drug Voyxact in patients with IgA nephropathy, a chronic autoimmune kidney disease. In the study, patients receiving Voyxact experienced an annualized…
    STAT · 3mo agoNegative readoutNeutral↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Scientists identify previously unknown HIV reservoir in the body
    Scientists have reported the discovery of a new location where HIV can hide within the human body. The finding expands the list of known viral reservoirs and suggests that the virus may persist in…
    STAT · 3mo agoNeutral↗ source
  • Utah Medical Board Criticized for Unilateral Stance on AI in Healthcare
    The Utah Medical Board faced rebuke after it took an independent approach to criticizing artificial intelligence tools used in medical practice. The criticism came as the state was running a pilot…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Rising AI battle between hospitals and insurers drives soaring medical bills, says pediatric cardiologist
    Darshak Sanghavi, a pediatric cardiologist and chief medical officer of Machinify, writes an opinion piece about an emerging AI conflict between health providers and insurers over patient records a…
    STAT · 3mo agoNegative↗ source
  • Military culture may increase risk of eating disorders among men, expert warns
    Paula Chesley, a yoga and meditation instructor who works with people with eating disorders, notes that male clients are rare but many have served in the military. She says that, based on her expe…
    STAT · 3mo agoNegative↗ source
  • Public health must address the rapidly growing Amish population, experts say
    The STAT First Opinion podcast highlighted that the Amish community is expanding quickly, roughly doubling every two decades, which will increasingly affect public health planning. Researchers Bra…
    STAT · 3mo agoNeutral↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Celcuity's gedatolisib trial cuts death risk but misses investor expectations
    Celcuity reported data from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR‑positive, HER2‑negative breast cancer with PIK3CA mutations. The trial enrolled 350 patients who had progresse…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Telemedicine surge could eliminate traditional doctor’s office waiting rooms
    Emergency physician Iyesatta Massaquoi Emeli reflects on how the concept of waiting has been built into medical practice, from the lobby to the triage process, shaping patients' experience of care.…
    STAT · 3mo agoPositive↗ source
  • Servier to acquire Edgewise's experimental muscular dystrophy drug in $2.7B deal
    Servier, a French pharmaceutical company, announced it will acquire the muscular dystrophy business of Colorado biotech Edgewise Therapeutics. The deal centers on sevasemten, an experimental oral…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • ASCO meeting highlights grief alongside cancer data, honoring late oncologist Amy Lin
    At the annual American Society of Clinical Oncology meeting, scientists presented abundant new cancer data, but this year the program also gave space to the emotional side of oncology. Outgoing pr…
    STAT · 3mo agoNeutral↗ source
  • Croatian researcher’s five-decade quest to uncover BPC-157’s potential draws FDA attention
    In 1975 a second‑year medical student at the University of Zagreb heard a lecture on stress and the stomach lining. He imagined the organ produced a natural anti‑stress chemical and set out to find…
    STAT · 3mo agoNeutral↗ source
  • FDA misses self-imposed deadline on electric shock device ban, prompting disability advocates' outcry
    The Food and Drug Administration did not issue a decision by the end of May as it had set for itself on whether to prohibit electrical shock devices used on people with intellectual disabilities an…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Hospitals grapple with patient requests for unvaccinated donor blood
    Some patients are now asking hospitals to provide blood that comes only from donors who have not received any COVID-19 vaccine, creating a new set of ethical and logistical questions. The demand r…
    STAT · 3mo agoNeutral↗ source
  • Residency dismissals disproportionately affect Black and Latino trainees despite medical school diversification
    Medical schools have made notable progress in diversifying their student bodies, with enrollment of Black and Latino students rising over the past decade through pipeline programs, scholarships, an…
    STAT · 3mo agoNegative↗ source
  • Revolution Medicines' daraxonrasib nearly doubles survival in pancreatic cancer trial
    Data presented at the American Society of Clinical Oncology meeting showed that Revolution Medicines' experimental drug daraxonrasib significantly extended survival for patients with metastatic pan…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Ivonescimab cuts death risk by one-third in Chinese lung cancer trial, adds four-month survival
    A trial in China evaluated ivonescimab combined with chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. The study was presented at the American Society of Clinical O…
    BioPharma Dive · 3mo agoPositive readoutNeutral↗ source
  • Experts say Grail’s multi-cancer blood test not yet ready for routine screening
    At the ASCO 2026 meeting in Chicago, Grail presented its multi-cancer early detection blood test, which the company markets as a tool to identify several cancers at an early stage. Independent exp…
    Endpoints · 3mo agoNegative↗ source
  • Bristol Myers reports Phase 3 data showing mezigdomide extends survival in relapsed multiple myeloma
    Bristol Myers Squibb presented Phase 3 results for its experimental multiple myeloma drug mezigdomide at the American Society of Clinical Oncology meeting. The study evaluated mezigdomide combined…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source