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595 stories matching this filter · ← front page

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  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 1d agoApprovalPositive↗ source
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Infectious Disease356
  • Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance
    The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
    raps · 1d agoRegulatoryNeutral↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdles
    The U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
    raps · 1d agoApprovalPositive↗ source
  • Experts call for modernizing rare disease evidence models using FDA plausible mechanism framework
    A recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
    raps · 1d agoNeutral↗ source
  • Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event
    Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported. The trial, which began in early…
    Fierce Biotech · 20h agoCRLNeutral↗ source
  • EMA launches consultation on draft framework to speed adoption of data standards
    EMA has opened a public consultation on a draft framework aimed at accelerating the implementation of data standards across the pharmaceutical sector. The agency says the new framework is intended…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 1d agoApprovalPositive↗ source
  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 1d agoRegulatoryPositive↗ source
  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 1d agoCRLNegative↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump announced his intent to nominate Heidi Overton, M.D., Ph.D., a current White House aide, to lead the Food and Drug Administration. Overton earned her medical degree from the…
    Fierce Biotech · 2d agoRegulatoryNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck & Co. has entered a collaboration with the Sarah Cannon Research Institute to expand patient access to oncology trials at community sites across the United States. The partnership will use S…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Biotech and Academia Explore New Partnership Models to Boost Drug Development
    The article notes that declining alternative funding and a drop in research grants are forcing biotech companies and universities to rethink how they collaborate. At the 2026 Chief Medical Officer…
    Fierce Biotech · 2d agoPositive↗ source
  • Emerging Biotechs Can Speed Development with Tailored Global Trial Strategies, Panel Says
    A panel of biotech chief medical officers and CRO executives discussed how small biotechs can accelerate clinical development by using fit-for-purpose global trial designs. They highlighted both t…
    Fierce Biotech · 2d agoNeutral↗ source
  • President Trump nominates White House aide Heidi Overton as FDA Commissioner
    President Donald Trump announced on his Truth Social platform that Heidi Overton, a White House aide, will be nominated to lead the U.S. Food and Drug Administration. Overton is set to replace Mar…
    raps · 2d agoRegulatoryNeutral↗ source
  • Pharma execs discuss how to evaluate biotech partners and acquisition targets
    A recent CMO Summit 360° webcast brought together biotech chief medical officers and pharma representatives to talk about how pharma teams assess biotech companies for partnerships or acquisitions.…
    Fierce Biotech · 2d agoNeutral↗ source
  • 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 · 1d 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 · 1d agoCRLNegative↗ source
  • 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 · 1d 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 · 2d 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 · 2d 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 · 3d agoDealPositive↗ source