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  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 2h agoApprovalPositive↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 6h agoApprovalPositive↗ source
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  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 6h agoApprovalPositive↗ source
  • FDA clears Roche and Eli Lilly's blood test for early Alzheimer’s detection
    The U.S. FDA has granted clearance for a new blood test developed by Roche and Eli Lilly that measures phosphorylated tau 217 (pTau217) to help rule in or rule out Alzheimer’s disease. The Elecsys…
    BioPharma Dive · 4h agoApprovalPositive↗ source
  • Haisco Pharmaceutical partners with ARCH Venture Partners and Population Health in new China-focused deal
    Haisco Pharmaceutical, a China-based drugmaker, has continued its active summer dealmaking by striking a new partnership. The partnership brings together ARCH Venture Partners, a venture capital f…
    Endpoints · 6h agoDealPositive↗ source
  • OmicsBank secures $2.25M to expand overseas patient data platform for biopharma
    OmicsBank announced it has closed a $2.25 million financing round aimed at scaling its platform that aggregates patient health data from overseas sources for use by biopharma companies. The compan…
    Endpoints · 7h agoDealPositive↗ 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 · 8h agoNeutral↗ source
  • Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials
    The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…
    Endpoints · 2h agoRegulatoryNeutral↗ source
  • Massachusetts biotech startups see funding gap widen as seed rounds shrink and Series A deals surge
    A MassBio report shows that mature biotech firms in Massachusetts captured most of the venture capital in the first half of 2026, with nearly $3.5 billion invested, a 25% rise from the same period…
    BioPharma Dive · 16h agoNeutral↗ source
  • Bristol Myers Squibb ends partnership with Cellares, prompting the cell therapy maker to restructure
    Bristol Myers Squibb announced that it is terminating its collaboration with Cellares after completing a comprehensive evaluation of the partnership. The decision was driven by BMS’s assessment th…
    Endpoints · 8h agoDealNegative↗ source
  • FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detected
    The FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
    BioPharma Dive · 1d agoRegulatoryNegative↗ 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 · 1d agoRegulatoryNeutral↗ source
  • TwinStrand wins patent lawsuit as GSK’s hepatitis B therapy receives Japanese approval
    TwinStrand Biosciences, a DNA sequencing spin‑out from the University of Washington, announced it has prevailed in a patent infringement lawsuit against a California‑based competitor. The court’s…
    Endpoints · 1d agoApprovalPositive↗ source
  • Roche to acquire Hanmi's lean-mass preserving obesity shot in $2.3 bn deal
    Roche announced a partnership with South Korean company Hanmi Pharm to obtain rights to a novel obesity drug outside South Korea. Under the agreement, Roche will pay $190 million upfront and could…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA alerts users to destroy AVID Medical IV start kits containing recalled BD ChloraPrep applicators due to fungal contamination risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert warning that certain AVID Medical convenience kits may pose a high‑risk fungal contamination problem because they contain…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • DC judge dismisses Merck's challenge to Medicare drug price negotiations
    A Washington D.C. federal judge rejected Merck's lawsuit contesting Medicare drug price negotiations under the Inflation Reduction Act. Judge Colleen Kollar-Kotelly of the U.S. District Court for t…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Regenxbio faces second FDA clinical hold, delaying Hunter syndrome gene therapy filing
    Regenxbio announced that its gene therapy for Hunter syndrome has received a second clinical hold from the FDA this year. The company said it no longer expects to submit an NDA or seek approval in…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • 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 · 1d 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 · 1d agoDealNeutral↗ source
  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 1d agoNeutral↗ source
  • FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA alerts to potential fungal contamination in Medline kits containing recalled BD ChloraPrep applicators
    The Center for Devices and Radiological Health (CDRH) has issued an Early Alert to warn the public about a possible high-risk device problem involving Medline convenience kits. Medline has sent a…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 1d agoRegulatoryNeutral↗ source
  • 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 · 1d agoLayoffsNegative↗ source