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805 stories matching this filter · ← front page

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  • Revolution Medicines reports $198 million Q3 sales for pancreatic cancer drug Rasonque, calling it best oncology launch ever
    Revolution Medicines' new pancreatic cancer drug Rasonque generated $198 million in revenue in the third quarter, far exceeding analyst expectations of $50‑100 million. The drug received FDA appro…
    BioPharma Dive · 7d agoPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 6d agoRegulatoryNegative↗ source
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  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • T-Therapeutics secures $133 million Series B to advance bispecific cancer and autoimmune drugs
    T-Therapeutics, a UK-based biotech focused on T-cell engager technology, announced a $133 million Series B financing. The capital will be used to generate proof-of-concept data for its lead bispec…
    BioPharma Dive · 7d agoDealPositive↗ source
  • Alethio Therapeutics secures $90 million to develop treatments for rare blood cancers
    Alethio Therapeutics, a UK based biotechnology startup, announced it has raised $90 million in new financing. The capital will be used to advance its pipeline targeting myeloproliferative neoplasm…
    BioPharma Dive · 7d agoDealPositive↗ source
  • Novo Nordisk lifts 2026 profit outlook after Wegovy obesity pill beats forecasts
    Novo Nordisk announced on Wednesday that it is raising its full-year profit and sales guidance after the third-quarter results for its Wegovy obesity pill came in above analysts' expectations. The…
    BioPharma Dive · 8d agoEarningsPositive↗ source
  • CVS to split into two companies, separating Aetna and Caremark from its retail pharmacies
    CVS Health announced it will divide the business into two independent companies, one that will contain its insurance unit Aetna and pharmacy‑benefit manager Caremark, and another that will operate…
    BioPharma Dive · 8d agoNeutral↗ source
  • Sanofi halts development of Nurix-partnered STAT6 degrader, triggering sharp drop in Nurix stock
    Sanofi announced it is ending work on SAR448272, an experimental oral drug that was intended to degrade the STAT6 protein, which is linked to inflammatory diseases. The biotech firm Nurix, which l…
    BioPharma Dive · 8d agoNegative↗ source
  • Analysts predict biopharma gains as Democrats take Congress control
    Analysts say the biopharma sector is set to benefit from the recent shift in U.S. Congress, with Democrats now holding majorities in both the House and Senate. They note that drug‑pricing debates…
    BioPharma Dive · 8d agoPositive↗ source
  • Medicare Part D premiums expected to rise 50% on average in 2027, KFF warns seniors to compare plans
    KFF analysis shows average monthly premiums for Medicare Part D standalone plans will jump from $34 to $51 in 2027, a 50% increase if seniors stay in their current plans. Premiums vary widely acro…
    BioPharma Dive · 9d agoRegulatoryNegative↗ source
  • Compact Medical issues recall and updated instructions for ButterflyBVM bag-valve-mask resuscitators due to bellows holes
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk problem with certain Compact Medical ButterflyBVM bag‑valve‑mask devices. Compact Medical…
    fda medwatch · 9d agoCRLNegative↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 9d agoRegulatoryNeutral↗ source
  • Vertex, ahead of FDA decision, calms fears surrounding kidney drug
    On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
    BioPharma Dive · 9d agoEarningsNeutral↗ source
  • Karyopharm files for Chapter 11 and plans auction with Gamida Cell parent Ayrmid as lead bidder
    Karyopharm Therapeutics, a cash-strapped cancer drugmaker, announced a Chapter 11 filing on Monday and will conduct a court-supervised auction of the company. Ayrmid, the parent of cell-therapy co…
    BioPharma Dive · 10d agoDealNegative↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 10d agoEarningsNeutral↗ source
  • FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliff
    The U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…
    BioPharma Dive · 10d agoRegulatoryNeutral↗ source
  • Pharma leaders turn to integrated scenario modeling as US MFN pricing reshapes global launch strategies
    The article explains that integrated scenario modeling is becoming a key tool for pharmaceutical executives facing pricing uncertainty and the complexities of worldwide product launches. It refere…
    BioPharma Dive · 10d agoNeutral↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 10d agoRegulatoryNeutral↗ source
  • FDA warns against Once Upon a Farm Tractor Wheels toddler bars due to choking risk
    The U.S. Food and Drug Administration issued a consumer safety advisory concerning the organic toddler snack Once Upon a Farm Tractor Wheels. The agency cautioned that the soft‑baked bars pose a p…
    fda medwatch · 10d agoRegulatoryNegative↗ source
  • MedWatch Alert: FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars
    Consumers Should Not Buy or Serve Once Upon a Farm Tractor Wheels, Organic Toddler Soft-Baked Bars Due to a Potentially Fatal Choking Hazard
    fda medwatch · 10d ago↗ source
  • Moderna and Merck’s individualized cancer vaccine shows promising melanoma results but shares tumble after ESMO presentation
    Investors closely watched the European Society for Medical Oncology (ESMO) meeting for updates on an individualized neoantigen cancer vaccine being co‑developed by Moderna and Merck. The therapy, c…
    BioPharma Dive · 13d agoPositive readoutNeutral↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 13d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 13d agoDealPositive↗ source
  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 13d agoCRLNegative↗ source
  • Aspen Neuroscience raises $140M IPO to advance Parkinson’s cell therapy
    Aspen Neuroscience, a San Diego biotechnology company, completed an initial public offering, selling roughly 9.4 million shares at $15 each and raising about $140.6 million. The capital will be di…
    BioPharma Dive · 13d agoDealPositive↗ source