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1,772 stories matching this filter · ← front page

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  • Roche commits over $1 billion to DualityBio for ADC development targeting TOP1 resistance
    Roche's Genentech unit announced a major investment in DualityBio to advance antibody-drug conjugate (ADC) technology. Under the agreement DualityBio will receive an upfront payment of $45 million…
    Endpoints · 2mo agoDealPositive↗ source
  • Cytokinetics aims for broader Myqorzo approval next year after supportive trial data
    Cytokinetics reported new data on its cardiac therapy Myqorzo, presented at a European scientific meeting. The results reinforce the drug’s efficacy in a specific heart muscle disorder. The compan…
    Endpoints · 2mo agoApprovalPositive↗ source
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fda medwatch111
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Nephrology759
  • FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits
    The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach. The company sent a letter on A…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • Everything Sprouts expands voluntary recall of Robust Radish Sprout Mix over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC announced an expansion of its voluntary recall to include additional lots of its 5‑oz Robust Radish Sprout Mix after identifying a potential contamination risk. The company…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • Daiichi Sankyo to restructure its commercial organization, appointing Ken Keller as chief commercialization officer
    Daiichi Sankyo announced plans to overhaul its commercial operations, with a split of its commercialization activities slated for April 1, 2027. The company has appointed veteran executive Ken Kel…
    Endpoints · 2mo agoNeutral↗ source
  • Panorama Produce recalls 302 boxes of mangoes over possible Salmonella contamination
    Panorama Produce announced a recall of 302 boxes of size 9 mangoes because they may be contaminated with Salmonella. The recalled mangoes were distributed from August 10 to August 21, 2026 to Conn…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • FDA approves Roivant's oral dermatomyositis drug Lisraya (brepocitinib)
    The U.S. Food and Drug Administration has granted approval to Roivant's drug brepocitinib, which will be sold under the brand name Lisraya. The decision marks the first major regulatory clearance f…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Gilead secures another FDA approval for HIV therapy, bolstering lenacapavir portfolio
    Gilead Sciences announced that the U.S. Food and Drug Administration has approved a new HIV treatment, adding to the company's growing portfolio of antiviral drugs. The approval extends the reach o…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Fifth Circuit Court rejects pharma industry's challenge to Medicare negotiation rules
    The Fifth Circuit Court of Appeals issued a ruling that ends the pharmaceutical industry's legal effort to overturn Medicare's negotiation framework. The court denied the industry's request, markin…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Eli Lilly stops disclosing Phase 1 pipeline, prompting mixed reactions
    Eli Lilly announced that it will no longer publicly share details of its Phase 1 drug candidates. The policy shift comes as the company’s GLP-1 product continues to generate the highest sales among…
    Endpoints · 2mo agoNeutral↗ source
  • CMS GLP-1 pilot shows early uptake and health benefits for seniors, signaling broader weight-loss drug access
    CMS launched a federal pilot program to expand access to GLP-1 weight-loss medications for seniors. After about two months, early data show that enrollment is rising and participants report improv…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • Moderna to raise $2 billion via convertible senior notes to fund oncology expansion and reduce debt
    Moderna announced it will issue $2 billion of convertible senior notes. The company says the financing will give it flexibility to invest in its growing oncology portfolio and to repay existing deb…
    Endpoints · 2mo agoDealNeutral↗ source
  • Lonza appoints Samanta Cimitan as chief commercial officer as WuXi Biologics posts revenue surge
    Lonza said it will create a new chief commercial officer position and has selected Samanta Cimitan, the current chief executive of Celonic, to take the role on Jan. 1 next year. Cimitan will be re…
    Endpoints · 2mo agoPositive↗ source
  • Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices. The proble…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • Akeso CEO says biliary tract cancer data could be a breakthrough
    Akeso’s chief executive Michelle Xia told ChinaPharma that the company’s PD-1xVEGF bispecific antibody, ivonescimab, is generating strong interest after early biliary tract cancer results. She not…
    Endpoints · 2mo agoPositive↗ source
  • Metriport secures $26 million Series A to streamline doctor access to patient data
    Metriport, a health-tech startup focused on simplifying how physicians obtain patient information, announced a $26 million Series A financing. The round was led by Matrix, with participation from…
    Endpoints · 2mo agoDealPositive↗ source
  • AVID Medical issues correction for convenience kits containing recalled Medline Namic Star Off-Handle manifolds
    AVID Medical has sent a letter to customers directing a correction of certain convenience kits that include manifolds affected by the Medline Namic Angiographic Star Off-Handle manifold recall. Th…
    fda medwatch · 2mo agoCRLNegative↗ source
  • Generate:Biomedicines shares early Phase 1 respiratory data after ERS poster leak
    Generate:Biomedicines presented Phase 1 data for its respiratory disease candidate at the European Respiratory Society annual meeting. The presentation came after the conference posters were releas…
    Endpoints · 2mo agoNeutral↗ source
  • Venture investor Redesign Health shifts from studio model to firm amid AI-driven startup boom
    AI is allowing founders to launch companies faster, challenging traditional venture studios that create ideas internally. Redesign Health, known for its studio approach, is changing its strategy,…
    Endpoints · 2mo agoNeutral↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Biohaven secures up to $795 million partnership with SK Biopharma for global epilepsy drug rights
    Biohaven announced a commercial partnership for its late-stage epilepsy program. South Korea-based SK Biopharma has agreed to pay up to $795 million for worldwide rights to the company's Kv7 ion ch…
    Endpoints · 2mo agoDealPositive↗ source
  • MassBio CEO warns 2025 may be biotech's toughest year amid China and NIH challenges
    Massachusetts is widely regarded as the epicenter of biotech because of its world‑class research institutions and vibrant startup ecosystem. MassBio CEO Kendalle Burlin O’Connell said 2025 will pr…
    Endpoints · 2mo agoNegative↗ source
  • Haisco licenses inflammatory disease candidate to US startup Sentivera; ViiV's HIV drug cleared for newborns
    Haisco Pharmaceutical announced that it has granted a license to US biotech Sentivera for the ex‑China rights to an unnamed inflammatory‑disease candidate. The agreement gives Sentivera the ability…
    Endpoints · 2mo agoDealNeutral↗ source
  • Aurora Therapeutics halts lead CRISPR program and cuts staff
    Aurora Therapeutics, founded as the first company dedicated to developing custom CRISPR-based gene-editing medicines, announced a major restructuring. The firm said it is laying off several employ…
    Endpoints · 2mo agoLayoffsNegative↗ source