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  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 18d agoPositive readoutPositive↗ source
  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 18d agoDealPositive↗ source
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  • Akeso reports phase 3 overall survival win for ivonescimab in advanced biliary tract cancer
    Akeso announced that its bispecific antibody ivonescimab combined with chemotherapy improved overall survival in a China phase 3 trial for advanced biliary tract cancer, beating the standard regime…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • Deloitte urges advanced therapy makers to adopt AI-driven digital staff to overcome operational bandwidth limits
    Advanced therapy manufacturers are confronting an operational bottleneck as their pipelines expand rapidly. More than a thousand advanced therapies are in development and the U.S. patient pool is e…
    Fierce Biotech · 18d agoNeutral↗ source
  • FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosis
    The U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…
    Fierce Biotech · 18d agoApprovalPositive↗ source
  • Boston Scientific reports cyberattack that disrupts operations and order processing
    Boston Scientific disclosed in an SEC filing on Aug. 26 that it detected a cybersecurity incident the previous day, marking the latest medtech cyberattack of the year. The breach impacted several…
    Fierce Biotech · 18d agoNegative↗ source
  • Baxter recalls two lots of 0.9% Sodium Chloride Injection over possible fiberglass particles
    Baxter International announced a voluntary recall of two batches of its 0.9% Sodium Chloride Injection after detecting potential fiberglass particles in the solution. The company said the particul…
    fda medwatch · 18d agoCRLNegative↗ source
  • Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reports
    Boston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. The FDA classified the recall as the most serious…
    fda medwatch · 18d agoCRLNegative↗ source
  • UCSF maps over 1,800 protein interactions linked to autism, revealing new drug target opportunities
    UCSF scientists created a molecular map of autism by analyzing 100 risk genes, which uncovered more than 1,800 protein-protein interactions. The study found that about 87% of these connections had…
    Fierce Biotech · 17d agoPositive↗ source
  • 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 · 18d 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 · 17d agoNegative↗ source
  • Biotech entrepreneur Someit Sidhu launches JATT III Acquisition SPAC with $60M Nasdaq IPO
    Someit Sidhu, M.D., announced the formation of JATT III Acquisition, a new special purpose acquisition company that raised $60 million in an initial public offering on Nasdaq. The SPAC will seek t…
    Fierce Biotech · 18d agoDealNeutral↗ source
  • Industry groups call for clearer FDA guidance on QRIs in expedited IND pilot
    Pharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…
    raps · 18d agoRegulatoryNeutral↗ source
  • 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 · 18d 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 · 18d 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 · 18d agoApprovalPositive↗ source
  • McKesson to acquire Precision Medicine Group for $2.25 billion, boosting oncology capabilities
    McKesson, a Fortune 500 healthcare wholesaler, announced a $2.25 billion acquisition of privately held Precision Medicine Group. The deal will fold Precision into McKesson's oncology and multispec…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Sentivera secures up to $1.5 billion licensing deal for inflammatory disease candidate
    Sentivera, a biotech startup formed by investors behind Metsera, announced a licensing agreement with Shanghai-listed Haisco Pharmaceutical. Under the deal, Sentivera will pay Haisco $40 million u…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Implantica receives FDA approval for RefluxStop GERD implant after eight years since EU launch
    Implantica announced that the U.S. Food and Drug Administration has granted approval for its gastroesophageal reflux disease (GERD) implant, RefluxStop, following a rigorous Premarket Approval revi…
    Fierce Biotech · 19d 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 · 18d 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 · 19d 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 · 19d 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 · 19d agoCRLNegative↗ source
  • FDA grants Capricor three-month extension to review DMD cell therapy data
    The U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information…
    Fierce Biotech · 19d agoRegulatoryNegative↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 19d agoRegulatoryNeutral↗ source