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575 stories matching this filter · ← front page

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  • Amgen ends $500M Crohn’s disease collaboration with TScan, but TScan says pipeline strategy stays on track
    Amgen has terminated its collaboration with TScan Therapeutics that was aimed at Crohn’s disease, ending a deal that could have delivered up to $500 million in milestones. The partnership began in…
    Fierce Biotech · 26d agoDealNeutral↗ source
  • Optimal Balance Pharmacy recalls one lot of compounded glutathione injection over high endotoxin levels
    Optimal Balance Pharmacy announced a voluntary recall of a single lot of its compounded glutathione 200 mg/mL multi‑dose vials. The recall was triggered after internal testing detected elevated bac…
    fda recalls · 26d agoCRLNegative↗ source
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Infectious Disease464
  • Prince Bakery recalls several breads over undeclared milk and sesame allergens
    Prince Bakery Inc. of Bronx, New York announced a recall of multiple Prince brand breads because they may contain undeclared milk or sesame. The recall covers Sesame Italian Bread, Large Italian B…
    fda recalls · 26d agoRegulatoryNegative↗ source
  • Merck and Moderna’s personalized mRNA vaccine shows longer recurrence-free survival in phase 3 melanoma trial
    Merck and Moderna reported that their individualized mRNA cancer vaccine, given together with Keytruda, extended the time patients remained free of melanoma recurrence in a late-stage study. The p…
    Fierce Biotech · 26d agoPositive readoutPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck and Sarah Cannon Research Institute announced a collaboration to improve patient access to oncology trials at community sites across the United States. The partnership will use SCRI’s Accele…
    Fierce Biotech · 27d agoDealPositive↗ source
  • BioMarin to acquire Alesta Therapeutics for $275 million to expand bone disease pipeline
    BioMarin Pharmaceutical announced it will purchase Alesta Therapeutics for an upfront payment of $275 million. Alesta is developing an oral small-molecule drug, ALE1, aimed at treating hypophospha…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Craif raises $33M to expand its urine-based pancreatic cancer test
    AI biopharma Craif announced a $33 million Series D financing, bringing its total capital raised to $88 million. The funding will be used to scale research on its urine-based microRNA test, miSign…
    Fierce Biotech · 27d agoDealNeutral↗ source
  • J&J MedTech secures FDA 510(k) clearance for Monarch Quest 3 bronchoscopy software update
    Johnson & Johnson MedTech announced that its Monarch bronchoscopy robot has received FDA 510(k) clearance for the latest software version, Monarch Quest 3. This marks the fourth major software laun…
    Fierce Biotech · 27d agoRegulatoryPositive↗ source
  • Kolon TissueGene cuts 37 jobs after phase 3 osteoarthritis trial fails
    Kolon TissueGene announced it will lay off 37 employees at its Maryland headquarters, with the reductions set to take effect at the end of August. The cuts follow a phase 3 trial of the company’s…
    Fierce Biotech · 27d agoLayoffsNegative↗ source
  • Harvard researchers keep brain organoids alive for five years, tracking development
    A study published in Nature describes how researchers at Harvard University grew a human brain organoid from a blood sample and kept it alive in the lab for five years. During the five-year period…
    Fierce Biotech · 27d agoPositive↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 27d agoRegulatoryNeutral↗ source
  • BD advises recall of sodium chloride ampules in convenience kits after Huons Co. issue
    The FDA issued an Early Alert after Becton Dickinson (BD) sent a letter to customers about a potential high‑risk device issue. The alert concerns convenience kits and procedural trays that contain…
    fda medwatch · 27d agoRegulatoryNegative↗ source
  • FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways
    The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…
    raps · 27d agoRegulatoryNeutral↗ source
  • Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
    More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…
    raps · 27d agoRegulatoryNeutral↗ source
  • Study finds measuring non-clinical influences on FDA approvals is complex
    A new study examined how non-clinical factors might affect the U.S. Food and Drug Administration's drug approval decisions. Researchers concluded that quantifying such influences is challenging be…
    raps · 27d agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 27d agoRegulatoryNeutral↗ source
  • Dreyer’s Grand Ice Cream voluntarily recalls select Outshine Fruit Bars over possible glass contamination
    Dreyer’s Grand Ice Cream announced a voluntary recall of certain Outshine Fruit Bars after detecting possible foreign material contamination. The recall includes Strawberry, Watermelon, Grape, Tan…
    fda recalls · 26d agoCRLNegative↗ source
  • L-Nutra recalls Prolon Apulian Almond & Cocoa Spread due to undeclared cashews, pistachios, hazelnuts
    L-Nutra of Culver City, California announced a recall of its Prolon brand Apulian Almond & Cocoa Spread after testing found undeclared tree nut allergens. The affected product is sold in 8.47‑oz (…
    fda recalls · 27d agoRegulatoryNegative↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 28d agoApprovalPositive↗ source
  • Slate Medicines secures $245M financing and Nasdaq listing via reverse merger with Fulcrum Therapeutics
    Slate Medicines, a North Carolina biotech, is moving toward a Nasdaq listing through a reverse merger with Fulcrum Therapeutics, six months after emerging from stealth. The transaction includes a…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Chinese biotech CEOs say US tensions won’t curb booming licensing deals
    Chinese biotech CEOs say they are not worried about rising US political tension and regulatory scrutiny. US lawmakers have increased scrutiny, referencing the America First Investment Policy and t…
    Fierce Biotech · 28d agoNeutral↗ source
  • Amylyx's avexitide halves hypoglycemia episodes in phase 3 trial for post‑bariatric patients
    Amylyx Pharmaceuticals reported that its GLP‑1 receptor antagonist avexitide significantly reduced dangerous blood‑sugar drops in a phase 3 study. The double‑blind Lucidity trial enrolled 78 indiv…
    Fierce Biotech · 28d agoPositive readoutPositive↗ source
  • Leo Pharma signs $435 million deal with Tanabe for rare skin disease drug dersimelagon
    Leo Pharma announced a licensing agreement with Mitsubishi Tanabe Pharma for worldwide rights to dersimelagon, an oral melanocortin-1 receptor agonist targeting rare genetic skin disorders. The dr…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Baylor Genetics suffers cyberattack exposing patient and employee data
    Baylor Genetics, a diagnostic genomics company, announced that an unauthorized third party accessed portions of its network between June 11 and June 17. The breach involved a limited subset of pat…
    Fierce Biotech · 28d agoNegative↗ source