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1,266 stories matching this filter · ← front page

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  • Rebranded Rezera plans IPO to fund phase 3 trial of NLRP3 inhibitor ruvonoflast for peripheral artery disease
    Rezera, which rebranded from NodThera last month, announced plans for an initial public offering to raise capital for its lead candidate, ruvonoflast, a brain‑penetrant NLRP3 inhibitor. The compan…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Roche CEO says stance on $1.5B Poseida acquisition unchanged despite dropping one CAR-T program
    Roche bought Poseida in 2024 for $1.5 billion to secure its off-the-shelf CAR-T platform and strengthen its cell-therapy portfolio. During the third-quarter earnings call, the company said it has…
    Fierce Biotech · 19d agoDealNeutral↗ source
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  • GSK’s B7-H4 ADC shows 62% response in platinum-resistant ovarian cancer, PFS 11 months
    GSK’s global head of oncology R&D presented new early-stage data on its B7-H4‑directed antibody‑drug conjugate, mo‑rez, at the ESMO conference in Madrid. The update focused on the ongoing Behold‑1…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • FDA issues warning letters to Baxter and Olympus over GMP and QSR violations
    The U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…
    raps · 19d agoRegulatoryNegative↗ source
  • AbbVie’s lutikizumab meets primary endpoint in phase 3 hidradenitis suppurativa trial but falls short of competitive benchmarks
    AbbVie reported that its experimental antibody lutikizumab achieved the primary endpoint in the phase 3 Intrepid study for hidradenitis suppurativa. The trial enrolled about 1,400 patients and at…
    Fierce Biotech · 19d agoPositive readoutNeutral↗ source
  • Boehringer presents phase 1b data on obrixtamig showing strong response rates in second-line small cell lung cancer
    Boehringer Ingelheim presented updated data from its DAREON-9 phase 1b trial at the ESMO Congress in Madrid, evaluating the DLL3xCD3 bispecific T-cell engager obrixtamig in combination with topotec…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • Abbott to separate Nutrition business into independent publicly traded company
    Abbott announced it will separate its Nutrition business into a stand-alone publicly traded company. The spin‑off will be carried out via a tax‑free distribution of the new company's shares to Abb…
    Fierce Biotech · 19d agoNeutral↗ source
  • Ipsen executive urges scientists to look beyond first results to achieve patient impact
    Philippe Lopes-Fernandes, executive vice president and chief business officer at Ipsen, reflects on how scientific progress often requires moving past an initial finding. He notes that a result can…
    Fierce Biotech · 19d agoPositive↗ source
  • EMA opens consultation on platform trial methodology; MHRA to recognize CE-marked devices indefinitely
    The European Medicines Agency is launching a public consultation to gather feedback on the methodological aspects of confirmatory platform clinical trials. The agency seeks input from researchers,…
    raps · 19d agoRegulatoryNeutral↗ source
  • Natural Grocers recalls 2‑pound organic mung beans over possible glass contamination
    Vitamin Cottage Natural Food Markets, Inc. in Lakewood, Colorado announced a recall of Natural Grocers brand organic 2‑pound mung beans because of potential glass contamination. The recall follows…
    fda recalls · 18d agoRegulatoryNegative↗ source
  • WinCo Foods recalls hoagie rolls after undisclosed sesame ingredient
    WinCo Foods of Boise, Idaho announced a recall of its brand hoagie rolls because sesame was not listed on the label. The rolls, identified by UPC 2-70552-00649-2 and bearing best-by dates from Sep…
    fda recalls · 18d agoCRLNeutral↗ source
  • Roche reports up to 30% shrinkage of chronic MS lesions with fenebrutinib, eyes FDA approval
    Roche has filed for FDA approval of its BTK inhibitor fenebrutinib for both relapsing and primary progressive multiple sclerosis, after the agency accepted the submission. At the MSToronto2026 mee…
    Fierce Biotech · 20d agoPositive readoutPositive↗ source
  • Merck and Moderna release early phase 3 melanoma vaccine data showing primary endpoint success but weaker secondary results
    Merck and Moderna disclosed phase 3 data for their melanoma vaccine INTerpath-001 ahead of schedule after an embargo breach. The trial met its primary endpoint of recurrence‑free survival, with re…
    Fierce Biotech · 20d agoPositive readoutNeutral↗ source
  • Hologic acquires Spain’s Reveal Genomics to expand breast cancer genomic testing
    Hologic, a medical‑technology company, announced it will acquire precision‑oncology firm Reveal Genomics, based in Spain. Reveal Genomics develops advanced genomic diagnostic tests, notably the HE…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Wedgewood Pharmacy recalls multiple compounded veterinary meds over potency testing inconsistencies
    Wedgewood Pharmacy LLC announced a recall of certain compounded veterinary medications that are still within their expiration dates. The recall is due to inconsistencies in the reliability of anal…
    fda recalls · 19d agoCRLNegative↗ source
  • Astellas partners with AI Proteins on $400M computational drug discovery deal
    Astellas Pharma of Japan has entered a partnership with Boston based AI Proteins to apply its computational design platform to drug discovery. AI Proteins builds miniproteins from scratch using ar…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Biotech reverse mergers surge in 2026, reaching highest level since 2021 as PIPE financing spikes
    Biotech companies are using reverse mergers to re‑enter public markets at a rate not seen since 2021, according to a J.P. Morgan report released in October 2026. In the first nine months of 2026,…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Myriad Genetics sells prenatal testing business to Labcorp for $210 million
    Myriad Genetics announced it will divest its Prenatal Health testing division to Labcorp, receiving $210 million in cash. The transaction includes Myriad's Prequel, Foresight, SneakPeek and FirstG…
    Fierce Biotech · 20d agoDealNeutral↗ source
  • FDA device officials prioritize hiring after layoffs, express optimism for upcoming MDUFA VI agreement
    Top officials from the FDA's Center for Devices and Radiological Health spoke at a town‑hall session during The MedTech Conference. They said the agency is concentrating on rebuilding staff after a…
    raps · 20d agoRegulatoryPositive↗ source
  • Amid bepirovirsen triumph, GSK quietly scraps trial of next-gen hep B therapy
    GSK may have cemented its hepatitis B credentials with Tuesday’s landmark FDA nod for its “functional cure” bepirovirsen, but the pharma continues to rethink its strategy for next-gen candidates.
    Fierce Biotech · 20d agoRegulatoryNeutral↗ source
  • Pharma companies push FDA for risk-based flexibility in container-closure testing guidance
    Major pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…
    raps · 20d agoRegulatoryNeutral↗ source
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 20d agoApprovalPositive↗ source
  • Researchers develop tumor "avatar" model that predicts immunotherapy response with 93% accuracy
    Researchers at Elephas Biosciences, in collaboration with academic centers, created an ex vivo tumor "avatar" from patient biopsies to test how tumors respond to immunotherapy. They exposed 124 tu…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • AstraZeneca teams with Oracle on AI-driven clinical trials as FDA clears Haemonetics vascular closure system
    AstraZeneca announced a collaboration with technology firm Oracle to incorporate artificial intelligence into its clinical trial processes. The partnership aims to use Oracle's cloud and data analy…
    raps · 21d agoApprovalPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 21d agoApprovalPositive↗ source