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463 stories matching this filter · ← front page

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  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 21h agoRegulatoryNegative↗ source
  • Sionna’s cystic fibrosis flop sends stock down 90%, but a ‘significant positive’ for Vertex
    Sionna Therapeutics has axed a cystic fibrosis add-on program after flunking a phase 2 trial, eliminating a would-be challenger to Vertex Pharmaceuticals’ empire. The biotech plans to “take actions…
    Fierce Biotech · 19h agoNegative readoutNegative↗ source
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  • AbCellera's Phase 2 hot flash trial beats aggressive upside target, challenging Astellas and Bayer
    AbCellera announced that its Phase 2 study of ABCL635, an antibody that blocks the NK3R receptor, met its primary endpoint in postmenopausal women with hot flashes. The trial enrolled 92 participan…
    Fierce Biotech · 21h agoPositive readoutPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 19h agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concerns
    The U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because…
    Fierce Biotech · 18h agoCRLNegative↗ source
  • Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromab
    Scholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate…
    Fierce Biotech · 19h agoRegulatoryNeutral↗ source
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 19h agoPositive readoutPositive↗ source
  • FDA approves Labcorp's BRAF melanoma companion diagnostic
    The FDA has granted approval to Labcorp's companion diagnostic for advanced melanoma patients with specific BRAF mutations. The test, called PGDx elio tissue complete CDx, uses next-generation seq…
    Fierce Biotech · 21h agoApprovalPositive↗ source
  • Arpeggio Biosciences shuts down after Nrf2 drug program encounters off-target toxicity
    Arpeggio Biosciences, founded in 2018 in Boulder, Colorado, built its platform around a large nascent‑RNA sequence database and aimed to develop a small‑molecule degrader of the Nrf2 transcription…
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • aTyr Pharma cuts 60% of staff to fund second phase 3 trial of lung disease drug efzofitimod
    aTyr Pharma announced it will reduce its workforce by about 60%, leaving roughly 20 employees, to reallocate resources toward its lung disease program. The cut follows the company's previous phase…
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 1d agoCRLNeutral↗ source
  • Sobi pens $580M deal for Innate’s skin cancer drug ahead of phase 3 push
    Sobi has bought into Innate Pharma’s vision for lacutamab, handing the French biotech $75 million upfront for the rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer.
    Fierce Biotech · 22h agoDealNeutral↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 14h agoNeutral↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 14h agoNeutral↗ source
  • Recon: BMS plans $2.3B Houston manufacturing site; MHRA approves Lilly weight-loss drug for weight loss, type 2 diabetes
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Asia-Pacific Roundup: India establishes tougher penalties for filing misleading or fake documents
    The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.
    raps · 1d ago↗ source
  • FDA warns firm in India for falsified logbooks; two other companies warned for lax testing
    The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified logbooks to the agency. The agency also warned two other…
    raps · 1d ago↗ source
  • IMDRF details key principles for regulators to adopt PCCPs
    The International Medical Device Regulators Forum (IMDRF) has finalized a technical document outlining how regulatory agencies may adopt predetermined change control plans (PCCP). The document list…
    raps · 1d ago↗ source
  • Novo Nordisk and Amazon sign AI drug discovery pact, launch London innovation hub
    Novo Nordisk and Amazon Web Services will partner to leverage AI and accelerate drug discovery.
    Fierce Biotech · 1d ago↗ source
  • Novo Nordisk CFO sees oral Wegovy rollout boosting outlook and remains upbeat on CagriSema
    Novo Nordisk's chief financial officer, Karsten Munk Knudsen, discussed the company's second‑quarter earnings and the progress of the oral Wegovy pill during a recent interview. He highlighted that…
    Fierce Biotech · 3d agoEarningsPositive↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 3d agoDealPositive↗ source
  • BioMarin halts development of BMN 401 after phase 3 miss
    BioMarin Pharmaceutical announced it is ending all work on its experimental enzyme replacement therapy BMN 401 following a late‑stage trial that did not meet one of two primary goals in patients wi…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 3d agoLayoffsNegative↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 4d agoRegulatoryNeutral↗ source