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3,156 stories matching this filter · ← front page

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  • ADC Therapeutics' Zynlonta confirmatory trial shows higher death rates, clouding full approval prospects
    ADC Therapeutics is pursuing full FDA approval for its antibody-drug conjugate Zynlonta in patients with relapsed or refractory diffuse large B-cell lymphoma. In the confirmatory study presented,…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Revolution Medicines eyes broader use of daraxonrasib pending FDA submission
    Revolution Medicines' daraxonrasib has not yet been approved for metastatic pancreatic cancer after chemotherapy, but a recent ASCO plenary presentation generated strong interest. Analysts expect…
    STAT · 3mo agoRegulatoryPositive↗ source
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fda recalls67
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Psychiatry & CNS866
Ophthalmology494
Pain478
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Infectious Disease444
  • 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
  • Patient-focused AI apps turn smartphones into real-time visit scribes
    More than a quarter of U.S. medical practices now rely on AI-powered ambient scribes that record appointments and draft clinical notes for doctors. The technology, initially deployed for clinicians…
    STAT · 3mo agoDealPositive↗ source
  • ADC biotech Ona Therapeutics raises $86.6M in Series B to move two ADC candidates toward clinic
    Barcelona-based Ona Therapeutics announced a $86.6 million Series B financing round. The capital will be used to move two antibody‑drug conjugate (ADC) programs into early‑stage clinical testing.…
    Endpoints · 3mo agoDealPositive↗ source
  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Trump admin moves to politicize NIH grant officials, stripping job protections
    The White House issued an executive order that reclassifies thousands of civil‑service positions as political appointments under the so‑called Schedule F. The change would allow the administration…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Drug makers and patient groups call on FDA to suspend fast‑track voucher program
    The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic r…
    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
  • Acting FDA Commissioner Kyle Diamantas says he will not seek permanent appointment
    Acting FDA Commissioner Kyle Diamantas has indicated that he does not intend to remain in the role on a permanent basis. Sources close to the administration say that the search for a new permanent…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Acting FDA chief vows to shield rare-disease discussions from political influence
    Acting FDA Commissioner Kyle Diamantas met with executives from fifteen rare‑disease nonprofit groups and senior agency staff. During the gathering he emphasized a new approach that differs from th…
    Endpoints · 3mo agoRegulatoryPositive↗ 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
  • Elevance Health’s chief digital officer discusses practical AI applications for insurers
    Elevance Health interviewed its chief digital information officer, Ratnakar Lavu, about how health insurers are adopting artificial intelligence. Lavu, who previously held digital roles at Kohl’s,…
    Endpoints · 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
  • HHS says Americans with high-risk Ebola exposure can receive experimental antibody MBP-134 from Mapp Biopharma
    HHS announced that U.S. citizens who have had high-risk exposure to Ebola in the ongoing Central African outbreak will be eligible to receive an experimental antibody therapy. The treatment, ident…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Revolution Medicines' pancreatic cancer drug sparks standing ovation on biotech podcast
    The latest episode of STAT’s "The Readout LOUD" podcast highlighted a recent data presentation on Revolution Medicines’ pancreatic cancer candidate, daraxonrasib. Oncologists in the audience respo…
    STAT · 3mo agoNeutral↗ source
  • Health secretary RFK Jr. faces staffing gaps as top priority over vaccine initiatives
    Robert F. Kennedy Jr., in his second year as the nation’s health secretary, has spent much of the first half of the year traveling to farms, clinics and other sites across the United States. In in…
    STAT · 3mo agoNeutral↗ source
  • Study highlights gaps in male puberty research and links timing to future health risks
    Researchers note that most knowledge about puberty comes from studies in girls, leaving a substantial gap in understanding how the onset of puberty in boys affects later health. Emerging evidence…
    STAT · 3mo agoNeutral↗ source
  • STAT reporter highlights diverse crowd and science at California longevity festival Vitalist Bay
    Alex Hogan of STAT introduces a video dispatch about Sarah Todd's recent visit to Vitalist Bay, a longevity festival held in California. Todd reports that the event defies the common image of long…
    STAT · 3mo agoNeutral↗ source
  • Axsome secures settlement to keep Sunosi exclusive until 2040
    Axsome Therapeutics announced it has reached a settlement that pushes back the entry of generic versions of its narcolepsy medication Sunosi until 2040. The agreement was reached with the last rem…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Bipartisan House bill would require security review of U.S. biotech investments in China
    A bipartisan group of Representatives introduced legislation on Tuesday that would expand the Committee on Investment and National Security (COINS) Act to cover biotechnology. The bill, called the…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Eli Lilly partners with Ascidian Therapeutics on $1.9 b RNA exon-editing collaboration for kidney disease
    Eli Lilly and Boston-based Ascidian Therapeutics announced a research collaboration aimed at discovering medicines for genetically driven kidney diseases. The partnership leverages Ascidian’s RNA e…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Alnylam inks up to $2 billion AI partnership with Inceptive Nucleics for RNAi drug discovery
    Alnylam announced a three-year strategic collaboration with Inceptive Nucleics to develop AI foundation models for RNAi therapeutics. The agreement is valued at up to $2 billion, with an initial $…
    STAT · 3mo agoDealPositive↗ source
  • Highmark Health sues HaloMD over alleged sham arbitration letter and misleading price data
    Highmark Health, a Pennsylvania Blue Cross Blue Shield licensee with more than 7 million members, filed a complaint on June 1 in U.S. District Court in Western Pennsylvania accusing HaloMD of abusi…
    STAT · 3mo agoRegulatoryNegative↗ source