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1,195 stories matching this filter · ← front page

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  • Roche commits $190 million upfront to license Hanmi's early-stage muscle-building obesity drug, total deal up to $2.3 billion
    Roche announced it will pay $190 million upfront to license an early-stage obesity drug from South Korean company Hanmi Pharm. The compound is described as a non-incretin, muscle-building therapy a…
    Endpoints · 5h agoDealPositive↗ source
  • Option-to-acquire structures stay uncommon amid biotech's busy M&A season
    Biotech companies are experiencing one of the busiest deal-making years on record, with a flood of announced mergers and acquisitions. Two recent transactions have highlighted the option-to-acquir…
    Endpoints · 5h agoDealNeutral↗ source
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globenewswire health73
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Endocrinology & Metabolism392
Infectious Disease369
  • Cardio firms including AstraZeneca and Novartis to showcase heart drug data at ESC 2026
    At the European Society of Cardiology's annual meeting in 2026, several pharmaceutical companies will present cardiovascular data. The lineup includes AstraZeneca, Ionis, Cytokinetics, Novartis an…
    Endpoints · 1h agoNeutral↗ source
  • Regenxbio hit with another clinical hold for Hunter syndrome gene therapy
    Regenxbio said it no longer expects to file for FDA approval of its Hunter syndrome gene therapy in the near future after the program was slapped with its second clinical hold this year. The compan…
    Endpoints · 54m ago↗ source
  • FDA delays Capricor's deramiocel PDUFA date to review new data
    The FDA is pushing back its decision on Capricor Therapeutics’ problematic Duchenne muscular dystrophy therapy to review additional data for a more niche indication. The company on Monday said the…
    Endpoints · 1h ago↗ source
  • TwinStrand wins patent case; GSK’s hepatitis B drug approved in Japan
    TwinStrand Biosciences wins patent case: The DNA sequencing company, which spun out of the University of Washington, announced on Monday that it won a patent infringement lawsuit against a Californ…
    Endpoints · 1h ago↗ source
  • Qiagen appoints new chief executive after 9-month search
    Molecular diagnostics specialist Qiagen has a new CEO as Jonathan M. Pratt takes the reins.
    Fierce Biotech · 5h ago↗ source
  • TME holds onto $1B dream for brain cancer drug as search for partners nears conclusion
    TME Pharma’s hunt for a partner for its brain cancer drug is closer to bearing fruit as the German biotech clings onto its hope of generating $1 billion in peak sales from the asset.
    Fierce Biotech · 5h ago↗ source
  • Spruce’s successful FDA talks plant seeds for Q4 filing of ultra-rare disease drug
    Spruce Biosciences has taken another step toward filing for FDA approval of its ultra-rare disease drug candidate, ticking off some of the manufacturing tasks needed to submit the long-awaited appl…
    Fierce Biotech · 6h ago↗ source
  • Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings
    The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.
    Fierce Biotech · 8h ago↗ source
  • Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
    Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.
    Fierce Biotech · 8h ago↗ source
  • Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanism
    Roche has taken its obesity strategy into uncharted territory via a $190 million upfront payment for a clinical-stage urocortin-2 analog from South Korea’s Hanmi Pharm.
    Fierce Biotech · 11h ago↗ source
  • Merck and Moderna report positive topline results for personalized cancer vaccine
    A third death was reported in China’s expedited clinical trials, raising safety concerns for fast‑track studies in the region. Merck and Moderna announced positive topline data from their personal…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Everything Sprouts recalls alfalfa sprouts over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC, a Minneapolis‑based producer, announced a recall of certain lots of its alfalfa sprouts on August 22, 2026. The recall was triggered because the sprouts may be contaminate…
    fda recalls · 2d agoCRLNegative↗ source
  • Genentech pours $750M into new drug‑delivery device plant in Oregon; Bavarian Nordic pushes back Lyme vaccine trial
    Roche’s Genentech announced a $750 million investment to build a new drug‑delivery device manufacturing facility at its Hillsboro, Oregon campus. The plant is intended to expand the company’s capac…
    Endpoints · 3d agoDealNeutral↗ source
  • New study warns that Trump-era cuts to federal research could jeopardize cancer drug development
    A recent study examines how recent political moves to curtail federally funded research could affect cancer drug development. The analysis notes that over the past decade biopharma companies have…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • Replimune appoints former Genentech exec Michelle DiNapoli as chief commercial officer after accelerated melanoma approval
    Replimune announced that Michelle DiNapoli will become its chief commercial officer, starting August 18. DiNapoli previously held senior roles at Genentech, where she led commercial operations. Th…
    Endpoints · 3d agoPositive↗ source
  • Ambros Therapeutics merges with Werewolf, raises $150M to fund phase 3 trial of rare disease drug
    Ambros Therapeutics announced an all‑stock reverse merger with Werewolf Therapeutics, accompanied by a $150 million private placement. The transaction will see the combined company operate under th…
    Fierce Biotech · 3d agoDealPositive↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • HHS Secretary RFK Jr. seeks to soften U.S. vaccine recommendations
    HHS Secretary Robert F. Kennedy Jr. has issued a request for information seeking to soften government vaccine recommendations. The request, released on Friday, signals that the administration is s…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • GOP lawmakers urge FDA to reject Chinese trial data unless sites undergo recent agency audit
    Two Republican members of the U.S. House have asked the Food and Drug Administration to tighten its oversight of clinical data that originates from China. Their proposal would require the FDA to r…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem…
    fda medwatch · 3d agoCRLNegative↗ source
  • Early Alert: Portrait Core Services Software Issue from GE HealthCare
    Patients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
    fda medwatch · 3d agoRegulatoryNeutral↗ source
  • Fromm Family Foods recalls over 5,800 cases of wet dog food in US and Canada over possible metal contamination
    Fromm Family Foods LLC announced on August 21, 2026 that it is voluntarily recalling 3,852 cases of its Turkey Pâté Wet dog food and 1,973 cases of its Diner Classics Milo's Meatloaf Pâté Wet dog f…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • California chronic pain biotech co‑founded by Vivek Ramaswamy to go public via reverse merger
    A California biotech company that has developed a chronic pain medication already approved for use in Italy is preparing to list on a U.S. exchange. The firm, co‑founded by entrepreneur Vivek Rama…
    Endpoints · 3d agoDealNeutral↗ source