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963 stories matching this filter · ← front page

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  • 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 · 12d 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 · 12d agoApprovalPositive↗ source
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fda recalls48
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Psychiatry & CNS727
Ophthalmology425
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Endocrinology & Metabolism390
Infectious Disease362
  • AGC Biologics targets in-vivo gene therapies with stable producer lines and next-gen purification
    The industry is moving from ex vivo to in vivo gene delivery, a change that forces viral vector manufacturers to rethink scale, purity, cell lines and analytical methods. In in vivo approaches the…
    BioSpace · 12d agoPositive↗ 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 · 12d 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 · 12d agoLayoffsNegative↗ source
  • BMS's Cobenfy faces market hurdles as side effects limit uptake, MapLight eyes opportunity
    The FDA approved Bristol Myers Squibb's Cobenfy in 2024, marking the first novel schizophrenia treatment in 35 years and raising hopes for a new therapeutic approach. Since its launch, the drug ha…
    BioSpace · 12d agoNegative↗ 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 · 12d agoDealPositive↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 12d agoDealNeutral↗ source
  • Early regulatory operations planning key to submission-ready dossiers
    Regulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…
    BioPharma Dive · 12d agoRegulatoryPositive↗ 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 · 12d agoDealNeutral↗ source
  • Denali Therapeutics' Avlayah generates $3.6M in Q1, beating forecasts
    Denali Therapeutics reported that its newly launched Hunter syndrome therapy Avlayah earned $3.6 million in revenue during the first quarter after its April market entry. Analysts had projected ro…
    BioSpace · 12d agoPositive readoutPositive↗ 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 · 12d 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 · 12d agoNeutral↗ 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 · 12d agoDealPositive↗ 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 · 15d agoEarningsPositive↗ source
  • Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma
    Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment. Analysts at BMO Capital Markets project the drug could genera…
    BioSpace · 15d agoApprovalPositive↗ source
  • Revolution Medicines sees strong demand for pancreatic cancer drug daraxonrasib under compassionate use
    Revolution Medicines reports that more than 2,000 patients have received its pancreatic cancer candidate daraxonrasib through a compassionate use program. The company says the drug has been distri…
    BioPharma Dive · 15d agoPositive↗ source
  • Bristol Myers Squibb expands Nvidia partnership to build most powerful AI supercomputer for drug discovery
    Bristol Myers Squibb announced an expanded partnership with Nvidia that will give it the most powerful and energy-efficient Nvidia infrastructure owned by a life-science company. Nvidia says the p…
    BioPharma Dive · 15d agoDealPositive↗ 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 · 15d 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 · 15d agoNegative readoutNegative↗ source
  • Biopharma job postings rise 15% in Q2 as layoffs fall and M&A activity picks up
    The Q2 2026 BioSpace report shows a strengthening biopharma job market, with more openings and fewer layoffs compared with the prior year. Job postings on BioSpace were up 15% year-over-year and 1…
    BioSpace · 15d agoPositive↗ source
  • Intellia identifies HLA allele linked to severe liver enzyme spikes in ATTR gene therapy
    In November 2025, a patient died after receiving Intellia Therapeutics' investigational gene silencer for transthyretin amyloidosis, prompting a safety review of the company’s ATTR gene therapy pro…
    BioSpace · 15d agoRegulatoryNeutral↗ source
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 15d agoDealPositive↗ 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 · 15d 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 · 15d agoPositive↗ source