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2,107 stories matching this filter · ← front page

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  • Cellares to cut 100 jobs after losing contract with unnamed large pharma customer
    Cellares, a cell therapy manufacturing startup based in South San Francisco, announced it will lay off about 100 employees. The cuts follow the termination of a contract by an unnamed large pharma…
    BioPharma Dive · 2mo agoLayoffsNegative↗ source
  • FDA pushes back PDUFA date for Capricor's Duchenne therapy to review new data
    The U.S. Food and Drug Administration announced it has extended the PDUFA target date for Capricor Therapeutics' investigational Duchenne muscular dystrophy treatment. The agency said the extensio…
    Endpoints · 2mo agoRegulatoryNegative↗ source
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Nephrology764
  • Bausch + Lomb to launch Phase 3 trial of dry‑eye drop after Phase 2 miss
    Bausch + Lomb announced plans to move its dual‑action dry‑eye drop into a Phase 3 study. The decision follows a Phase 2 trial that did not meet its primary endpoint. CEO Brent Saunders said the r…
    Endpoints · 2mo agoNegative readoutNeutral↗ 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoPositive readoutPositive↗ 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 · 2mo agoEarningsNeutral↗ 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 · 2mo 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 · 2mo 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 · 2mo agoPositive↗ 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 2mo agoNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoDealNeutral↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Gray‑market copies of Lilly’s obesity drug retatrutide show weaker weight‑loss results, study finds
    A recent study examined the effectiveness of gray‑market versions of Eli Lilly’s triple‑agonist obesity drug retatrutide. The analysis found that patients using these unapproved copies experienced…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Three deaths in China’s investigator-initiated trials raise concerns over fast, low-cost clinical testing
    Three participants died while taking part in investigator-initiated trials in China, prompting renewed scrutiny of the country’s clinical testing practices. China’s system is prized for its low co…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Eli Lilly teams with Amplitude on taRNA vaccine platform as Otsuka ends psychedelic trial
    Eli Lilly announced a collaboration with Amplitude Therapeutics to co‑develop vaccine candidates using a trans‑amplifying RNA (taRNA) platform. The taRNA approach aims to boost antigen expression…
    Endpoints · 2mo agoDealNeutral↗ source
  • Medline recalls convenience kits with B. Braun bupivacaine component, urges correction before use
    Medline has issued a correction for a range of its convenience surgical kits after discovering that they contain components from B. Braun Medical that include bupivacaine hydrochloride in a dextros…
    fda medwatch · 2mo agoCRLNegative↗ source
  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 2mo agoRegulatoryNegative↗ source