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91 stories matching this filter · ← front page

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  • FDA alerts hospitals to purge cassette fault in Abiomed Impella controllers
    The FDA issued an Early Alert after identifying a problem with the purge cassette recognition in Abiomed’s Automated Impella Controllers, which could cause prolonged delays in mechanical circulator…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Venture funding for women’s health startups drops sharply after 2024 peak, AI may drive rebound
    Venture capital flowing into women’s health companies fell sharply after reaching record levels in 2024. A Silicon Valley Bank report shows total funding dropped from about $3.2 billion in 2024 to…
    BioPharma Dive · 2d agoNeutral↗ source
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Infectious Disease384
  • Roche signs $2.5 billion deal with Hanmi for experimental obesity drug targeting muscle loss
    Roche's Genentech unit has agreed to acquire global rights (outside South Korea) to Hanmi's clinical-stage urocortin-2 analog, HM17321, as part of a deal valued up to $2.5 billion. The agreement i…
    Fierce Biotech · 3d agoDealPositive↗ source
  • FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in Japan
    The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
    BioPharma Dive · 3d agoRegulatoryNeutral↗ source
  • 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 · 3d agoNeutral↗ source
  • Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
    The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
    fda medwatch · 3d agoRegulatoryNeutral↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 6d agoEarningsNeutral↗ source
  • Merck KGaA's US research site to cut 20 jobs amid broader R&D downsizing
    Merck KGaA's North American division, EMD Serono, announced it will lay off 20 employees at its Billerica, Massachusetts research site. The cuts are slated to take effect in the second half of Oct…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 13d agoRegulatoryPositive↗ source
  • Two undisclosed gene-therapy deaths raise doubts about China's fast-track trial pathway
    Two recent deaths in China’s early‑stage gene‑therapy trials have drawn international attention. Both patients suffered severe immune reactions after receiving high‑dose viral vector treatments, an…
    Fierce Biotech · 13d agoRegulatoryNegative↗ source
  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 13d agoRegulatoryPositive↗ source
  • Versa Vascular appoints former Medtronic heart franchise leader Bill Shields as CEO
    Bill Shields, who spent 15 years leading Medtronic’s structural heart franchise, is leaving the medtech giant to become chief executive of Versa Vascular, a startup developing tricuspid valve repai…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 16d agoDealPositive↗ source
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 17d agoDealPositive↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 17d agoCRLNeutral↗ source
  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 21d agoDealPositive↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 21d agoDealPositive↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 21d agoDealPositive↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 22d agoCRLNegative↗ source
  • Amgen halts development of early-stage obesity drug AMG 513, shifting focus to phase-3 candidate MariTide
    Amgen announced it is stopping work on AMG 513, an early-stage obesity therapy, during its second-quarter earnings call. The decision follows a previous FDA clinical hold in early 2025 that was la…
    Fierce Biotech · 23d agoNegative↗ source
  • KKR to acquire medtech maker Integer in $5.7 billion deal
    KKR announced an agreement to take Integer private for approximately $5.7 billion, offering $127 per share in cash to Integer stockholders. Integer, based in Plano, Texas, saw its shares rise abou…
    Fierce Biotech · 23d agoDealNeutral↗ source
  • Curium to acquire Lantheus in deal valued up to $8 billion
    Curium announced it will purchase all outstanding shares of Lantheus for $102.50 cash per share, with potential additional $12 per share via contingent value rights linked to sales milestones in pr…
    Fierce Biotech · 24d agoDealNeutral↗ source
  • Wall Street reacts negatively to AstraZeneca-Bristol Myers merger talks, shares tumble
    A report in the Financial Times, followed by Reuters, said AstraZeneca and Bristol Myers Squibb have been discussing a possible combination in recent months. The news triggered a sharp sell-off. A…
    BioPharma Dive · 24d agoDealNegative↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 27d agoNegative readoutNegative↗ source