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  • FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
    FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompt…
    BioSpace · 18d agoCRLPositive↗ source
  • Gilead agrees to pay $1.275 billion upfront for PepStar’s oral IL‑23 inhibitor, targeting J&J’s Icotyde
    Gilead Sciences has entered into a transaction to acquire PepStar Therapeutics' oral IL‑23 receptor inhibitor program. The deal is valued at $1.275 billion in upfront cash, roughly $1.3 billion as…
    Fierce Biotech · 18d agoDealPositive↗ source
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fda medwatch111
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Nephrology759
  • Bolt Biotherapeutics to acquire Prana Therapies in reverse merger, secured $120M financing
    Bolt Biotherapeutics announced a stock‑for‑stock reverse merger with Prana Therapies. The transaction is supported by a $120 million financing package. The deal will bring Prana’s lead antibody in…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Roche pays $55 million upfront to Zymeworks for global rights to trispecific antibody ZW209 targeting small-cell lung cancer
    Roche has agreed to pay Zymeworks an upfront sum of $55 million for worldwide rights to ZW209, a trispecific antibody being developed for small-cell lung cancer. ZW209 is designed to bind DLL3 on…
    Fierce Biotech · 18d agoDealNeutral↗ source
  • Roche bets up to $813M on Zymeworks’ lung cancer trispecific T cell engager
    Roche will pay Zymeworks $55 million upfront plus another $40 million once the partnership asset enters Phase 1b development and up to $718 million in additional milestones.
    BioSpace · 18d agoDealNeutral↗ source
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 18d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 18d agoNeutral↗ source
  • Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
    Gilead Sciences has picked up a new inflammatory disease program from China’s PepStar Therapeutics to pair with the Phase 2 inflammatory bowel disease asset emvistegrast.
    BioSpace · 18d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 18d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 18d ago↗ source
  • FDA approves GSK-Ionis antisense drug Hibsago, opening functional-cure market for hepatitis B
    The U.S. Food and Drug Administration has granted approval to Hibsago (bepirovirsen), a partnership product of GSK and Ionis Pharmaceuticals, marking the first antisense oligonucleotide cleared for…
    BioSpace · 19d agoApprovalPositive↗ source
  • Roivant's brepocitinib cuts steroid use in non-infectious uveitis in Phase 3 trials
    Roivant Sciences and its subsidiary Priovant reported that their TYK2/JAK inhibitor brepocitinib met all primary and secondary endpoints in two identical Phase 3 studies (Clarity‑1 and Clarity‑2) i…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Celltrion licenses Kaigene's preclinical antibody KG013 in deal worth up to $580.5 million
    Celltrion, a South Korean biotech, has entered into a licensing agreement with Maryland-based Kaigene for a preclinical monoclonal antibody known as KG013. KG013 is designed to block the prolifera…
    Fierce Biotech · 19d agoDealPositive↗ source
  • AbbVie’s HS drug lutikizumab meets Phase 3 goal but falls short of analyst expectations
    AbbVie reported that its investigational IL‑1α/β inhibitor lutikizumab achieved the primary endpoint in the Phase 3 INTREPID study for hidradenitis suppurativa, a chronic inflammatory skin disease…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • Menarini's Stemline signs $1.1 billion deal to license Georgiamune's preclinical cancer immunotherapy
    Georgiamune, a Maryland‑based immunology biotech, has granted Stemline Therapeutics, part of Italy's Menarini Group, exclusive worldwide rights to develop and commercialize its preclinical cancer c…
    Fierce Biotech · 19d agoDealPositive↗ source
  • FDA approves GSK hepatitis B drug; EQT to acquire Qiagen for $10.8 billion
    The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline's new hepatitis B therapy, marking a regulatory milestone for the company. Private-equity firm EQT announced a definit…
    raps · 19d agoPositive↗ source
  • US Treasury proposes COINS Act rules that restrict biotech investment in China but leave big pharma licensing deals untouched
    The U.S. Treasury Department released draft regulations that add biotechnology to the Comprehensive Outbound Investment National Security (COINS) Act, labeling pharmaceutical compounds as prohibite…
    Fierce Biotech · 19d agoRegulatoryNeutral↗ source
  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 19d agoRegulatoryPositive↗ source
  • CSL appoints GSK veteran Deborah Waterhouse as new CEO to steer company through challenges
    CSL announced that Deborah Waterhouse, former head of GSK's HIV business ViiV Healthcare and former president of GSK Global Health, will become its new chief executive. Waterhouse joins CSL as the…
    Fierce Biotech · 19d agoNeutral↗ source
  • Biohaven's ataxia drug resubmission accepted by FDA, shares surge 36%
    Biohaven’s experimental drug troriluzole, being developed for spinocerebellar ataxia, was previously rejected by the FDA because the agency questioned the design of the registrational trial. The co…
    BioSpace · 19d agoRegulatoryPositive↗ source
  • Medrio aims to unify clinical trial tools to ease complexity for biotech firms
    Mike Novotny, founder and CEO of Medrio, says that funding cycles, growing study complexity and fragmented technology are slowing clinical research, especially for small and midsize life‑science co…
    Fierce Biotech · 19d agoPositive↗ source
  • Biotech sector logs 31 IPOs in 2026, with four more slated, still far below 2021 boom
    Biotech IPO activity has accelerated this year, with 31 companies completing public offerings so far, according to BioSpace data. This figure exceeds the totals from each of the previous four year…
    BioSpace · 19d agoDealNeutral↗ source
  • Zentalis reports promising overall survival and response rates for oral WEE1 inhibitor azenosertib in platinum-resistant ovarian cancer
    Zentalis Pharmaceuticals presented early data from the phase 1b portion of its Denali study of azenosertib, an oral WEE1 tyrosine kinase inhibitor, in patients with platinum‑resistant ovarian cance…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • Investors Re-evaluate Kidney Disease as New Cell and Gene Therapy Strategies Emerge
    In a recent episode of BioSpace's Denatured podcast, the CEOs of ProKidney and Nephrogen discussed why kidney disease has long been a difficult indication for cell and gene-based medicines. The co…
    BioSpace · 19d agoPositive↗ source