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  • Spyre Therapeutics deprioritizes anti-TL1A rheumatoid arthritis candidate after modest Phase 2 results
    Spyre Therapeutics said on Tuesday it will shift resources away from its anti-TL1A antibody that was being developed for rheumatoid arthritis. The decision follows the Phase 2 study, which showed…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Cellares defends its cell therapy platform after Bristol Myers ends partnership
    Cellares, a cell therapy manufacturing startup, responded to criticism from Bristol Myers Squibb after the drugmaker terminated their agreement. Bristol Myers withdrew, saying Cellares' commercial…
    Endpoints · 2mo agoNegative↗ source
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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 · 2mo 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 · 2mo agoApprovalPositive↗ source
  • 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 · 2mo agoApprovalPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 2mo agoDealNeutral↗ 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 · 2mo 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 · 2mo agoDealPositive↗ source
  • Baxter voluntarily recalls one lot of anticoagulant sodium citrate solution over possible fiberglass particles
    Baxter International announced a voluntary recall of a single lot of its Anticoagulant Sodium Citrate Solution, USP, 250 mL, packaged in a VIAFLEX plastic container. The recall was triggered after…
    fda medwatch · 2mo agoCRLNegative↗ 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 · 2mo agoRegulatoryNeutral↗ source
  • Baxter Recalls One Lot of 70% Dextrose Injection Over Stainless Steel Particulate Risk
    Baxter International announced a voluntary recall of a single lot of its 70% Dextrose Injection after detecting potential stainless steel particles in the solution. The presence of these particles…
    fda medwatch · 2mo agoCRLNegative↗ 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 · 2mo agoDealNegative↗ 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 · 2mo agoApprovalPositive↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoDealNeutral↗ source
  • Vitruvias Therapeutics recalls one lot of 30 mg thyroid tablets over super potency risk
    Vitruvias Therapeutics announced a voluntary recall of a single lot (Lot No. 504950) of its 30 mg thyroid tablets to the consumer level. Testing confirmed the tablets could be superpotent, raising…
    fda medwatch · 2mo agoCRLNegative↗ 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ 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
  • 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