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875 stories matching this filter · ← front page

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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 · 3mo 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 · 3mo agoDealPositive
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fda medwatch111
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Nephrology760
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  • 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 · 3mo agoPositive readoutPositive↗ source
  • Vaderis raises $152 million Series B to launch Phase 3 trial for rare vascular disease
    Vaderis Therapeutics announced it has closed an oversubscribed $152 million Series B round to fund its AKT inhibitor program. The capital will support a newly launched Phase 3 study of the oral dr…
    Fierce Biotech · 3mo agoDealPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoLayoffsNegative↗ source
  • Regeneron Ventures leads $75 million Series A for eczema-focused antibody startup Infinimmune
    Infinimmune, a Bay Area biotech developing antibody therapies for eczema, announced a $75 million Series A financing round. The round was co-led by Regeneron Ventures and Playground Global, with p…
    Fierce Biotech · 3mo agoDealPositive↗ 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 · 3mo agoDealNeutral↗ source
  • Novo Nordisk partners with Amazon Web Services to boost AI-driven drug discovery, opens London hub
    Novo Nordisk announced a partnership with Amazon Web Services aimed at using artificial intelligence to speed up the discovery of new medicines. The collaboration will see AWS become Novo Nordisk's…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Taylor Fresh Foods recalls jalapeño-containing products over possible Salmonella contamination
    Taylor Fresh Foods announced a recall of finished products that contain jalapeño peppers after being notified of a voluntary recall by Coast Citrus Distributors due to potential Salmonella contamin…
    fda recalls · 3mo agoRegulatoryNegative↗ source
  • NatureBest Precut & Produce recalls jalapeño-containing products over possible Salmonella contamination
    NatureBest Precut & Produce LLC announced a voluntary recall of food items containing jalapeño peppers supplied by Coast Citrus Distributors because of potential Salmonella contamination. The reca…
    fda recalls · 3mo agoCRLNegative↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoLayoffsNegative↗ source
  • Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US states
    Roche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…
    Fierce Biotech · 3mo agoPositive↗ source
  • Lexunder’s Food to Live green powder recalled over possible Salmonella contamination
    Lexunder Inc., operating as Food to Live, announced a recall of its green powder products due to potential Salmonella contamination. The recall covers products sold nationwide in resealable pouche…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA grants emergency use authorization for CLiK Extra wound spray to prevent New World screwworm in livestock and wildlife
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra, a dicyclanil topical suspension designed to be applied around wounds. The authorization allows the pr…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 3mo agoApprovalPositive↗ source
  • BioNTech appoints former Sobi chief Guido Oelkers as new CEO
    BioNTech has filled its long-vacant chief executive position after a six-month search. The board selected Guido Oelkers, Ph.D., who most recently led Swedish pharmaceutical company Sobi. At Sobi,…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Tarsus to acquire Alkeus for $450 million, adding phase-3 retinal drug and oral Stargardt candidate
    Tarsus Pharmaceuticals announced it will buy Alkeus Pharmaceuticals in a transaction valued at $450 million. The deal consists of $270 million in cash and $180 million of Tarsus common stock, givi…
    Fierce Biotech · 3mo agoDealPositive↗ source