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93 stories matching this filter · ← front page

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  • ADARx, backed by AbbVie, files for IPO to fund clinical-stage siRNA programs
    ADARx Pharmaceuticals, a San Diego biotech supported by AbbVie, announced plans to pursue an initial public offering. The company says most of the IPO proceeds will be used to advance three clinic…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Novartis and Ionis's pelacarsen fails to cut heart events despite lowering Lp(a) levels
    Novartis and Ionis reported that pelacarsen, an RNA therapy aimed at lowering lipoprotein(a), did not reduce major cardiovascular events in a Phase 3 trial of over 8,000 patients. The study compare…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
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fda medwatch65
fda recalls62
fda press38
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Psychiatry & CNS858
Ophthalmology491
Pain469
Endocrinology & Metabolism466
Infectious Disease437
  • SEC and FDA sign three-year info-sharing pact to boost market integrity and public-health oversight
    The U.S. Securities and Exchange Commission and the Food and Drug Administration have entered into a three-year memorandum of understanding to expand cooperation and share information. The MOU is…
    Fierce Biotech · 5d agoRegulatoryPositive↗ source
  • K Health plans IPO by 2029 after recent funding round
    K Health, a virtual‑care company that uses AI, announced its intention to go public by 2029. CEO Allon Bloch made the comment after a recent fundraising round, signalling the firm is preparing for…
    Endpoints · 6d agoPositive↗ source
  • Eli Lilly to acquire Merida Biosciences for up to $2.88 billion, adding autoimmune antibody-degrading pipeline
    Eli Lilly announced a transaction to purchase Merida Biosciences for up to $2.875 billion, combining an upfront cash payment with future milestone payments. Merida, which emerged from stealth last…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Eli Lilly to acquire Merida Biosciences in near-$2.9 billion deal to expand immune-disease pipeline
    Eli Lilly announced it will buy privately held Merida Biosciences, a company that has created a technology to target and break down malfunctioning antibodies that drive many autoimmune disorders.…
    BioPharma Dive · 7d agoDealPositive↗ source
  • Verily, NVIDIA and NIH launch first multimodal AI model combining EHR and genomics
    Verily Health, in partnership with NVIDIA and the NIH All of Us Research Program, announced the development of a new foundation model that merges electronic health record data with genomic informat…
    BioPharma Dive · 7d agoPositive↗ source
  • FDA approves Priovant's Lisraya (brepocitinib) for rare skin disease dermatomyositis
    The U.S. Food and Drug Administration has cleared the first oral targeted treatment for dermatomyositis, a rare and disabling skin disorder. The medication, brepocitinib, will be sold under the br…
    BioPharma Dive · 10d agoApprovalPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 11d agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Study finds Lilly's obesity drug Zepbound may lower hospital and ER costs for older adults
    A real‑world analysis examined older patients with obesity or excess weight who were either treated with Eli Lilly’s drug Zepbound or not. The researchers tracked healthcare utilization over time t…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source
  • Qiagen names Jonathan M. Pratt as new chief executive after nine-month search
    Qiagen announced that Jonathan M. Pratt will take over as chief executive, ending a nine‑month search for a successor. Pratt arrives from Filtration Group, where he served as president and CEO. He…
    Fierce Biotech · 14d agoNeutral↗ source
  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 14d agoDealNeutral↗ 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 · 14d agoNegative readoutNeutral↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 18d agoApprovalPositive↗ 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 · 19d agoPositive readoutPositive↗ source
  • EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial
    EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet a…
    BioPharma Dive · 21d agoNegative readoutNegative↗ source
  • EyePoint’s Phase 3 eye drug falls short of Eylea, stock tumbles 70%
    EyePoint reported that its experimental treatment for wet age-related macular degeneration did not meet the efficacy endpoints in a Phase 3 trial when compared with the current standard, Eylea. The…
    Endpoints · 21d agoNegative readoutNegative↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 21d agoCRLNegative↗ source
  • Skye Bioscience and Redx Pharma combine to form Fibrx Therapeutics with $125M financing for fibrosis pipeline
    Skye Bioscience announced a combination with privately held Redx Pharma, creating a new public company called Fibrx Therapeutics. The transaction is structured as a reverse merger and provides $12…
    Fierce Biotech · 24d agoDealPositive↗ source
  • BioCryst to rely on external partnerships after ending internal discovery programs
    BioCryst Pharmaceuticals CEO Charlie Gayer told Fierce that the company remains committed to science and research even as it shuts down its internal discovery efforts. Earlier this year the firm’s…
    Fierce Biotech · 24d agoNeutral↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Hemab Therapeutics IPO raises $301.5M, stock triples and funds runway to 2029
    Hemab Therapeutics completed an upsized $301.5 million IPO in May, boosting total proceeds to $346.7 million. The offering helped the company’s share price climb from $18 at debut to $53.48 by mid‑…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Abbott partners with Google Health to add AI-driven insights to its Lingo glucose wearable
    Abbott and Google Health announced a partnership that will combine Abbott's Lingo consumer glucose wearable with Google Health's artificial‑intelligence platform. The integration will let Lingo us…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Aura Biosciences cuts 20% of staff and reshuffles C-suite to focus on ocular oncology
    Aura Biosciences announced it is eliminating about one-fifth of its workforce as part of a broader restructuring under its new chief executive officer, Natalie Holles, who took the helm in April.…
    Fierce Biotech · 27d agoLayoffsNeutral↗ source