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63 stories matching this filter · ← front page

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STAT1024Endpoints774BioPharma Dive296BioSpace214Fierce Biotech203onclive165raps74globenewswire health
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  • Health systems deploy AI chatbots to streamline patient record review
    Several large health systems are rolling out generative AI chatbots that can query and summarize electronic medical records. Clinicians report that the tools save time and help uncover information…
    STAT · 7h agoPositive↗ 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 · 1d agoPositive readoutPositive↗ source
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fda recalls47
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Psychiatry & CNS712
Ophthalmology420
Endocrinology & Metabolism378
Pain372
Infectious Disease346
  • Leo Pharma to license Tanabe’s oral drug for rare light-sensitive skin disease, paying up to $435 million
    Leo Pharma announced a licensing agreement with Japan's Tanabe Pharma for an oral treatment targeting two genetic skin disorders that cause pain when exposed to sunlight. Under the deal, Leo Pharm…
    Endpoints · 2d agoDealNeutral↗ source
  • Leo Pharma signs $435 million deal with Tanabe for rare skin disease drug dersimelagon
    Leo Pharma announced a licensing agreement with Mitsubishi Tanabe Pharma for worldwide rights to dersimelagon, an oral melanocortin-1 receptor agonist targeting rare genetic skin disorders. The dr…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 8d agoNegative↗ 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 · 10d agoDealPositive↗ 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 · 10d 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 · 10d agoApprovalPositive↗ 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 · 10d agoDealNeutral↗ source
  • AI will further erode physician autonomy, says former surgeon
    Frances Mei Hardin, a former ENT surgeon and consultant, argues that artificial intelligence will not increase doctors' independence but will further reduce it. She points out that the same top-do…
    STAT · 13d agoNegative↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund anti-itch drug development
    Attovia Therapeutics completed an initial public offering that generated $289 million in gross proceeds. The company sold 17 million shares at $17 each, exceeding its original target of $182.4 mill…
    Fierce Biotech · 15d agoDealPositive↗ source
  • Sanofi pauses phase 2 bronchiectasis trial of SAR445399 for strategic reasons
    Sanofi has halted a phase 2 study of its monoclonal antibody SAR445399 in adults with non‑cystic fibrosis bronchiectasis. The trial, which began in April, was a randomized, double‑blind, placebo‑co…
    Fierce Biotech · 15d agoNegative↗ source
  • Smith & Nephew lowers 2026 sales outlook as US knee implant revenue falls 7%
    Smith & Nephew announced a revision to its 2026 sales outlook, now expecting underlying revenue growth of about 4% versus the prior 6% target. The change follows a second‑quarter report showing re…
    Fierce Biotech · 16d agoEarningsNegative↗ source
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 16d agoNeutral↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 17d agoRegulatoryNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 17d agoRegulatoryNeutral↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 21d agoNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 21d agoRegulatoryNeutral↗ source
  • A decade after WHO recognition, mycetoma is still one of the world’s most neglected diseases
    Borna Nyaoke-Anoke, a physician leading mycetoma work at the Drugs for Neglected Diseases initiative, reflects on a decade since the World Health Organization formally acknowledged the disease. Sh…
    STAT · 21d agoNegative↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 21d agoPositive readoutPositive↗ source
  • FDA advisory panel advises against approving Capricor’s Duchenne cell therapy, deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee convened to evaluate deramiocel, a cell‑based treatment for Duchenne muscular dystrophy developed by Capricor Therapeutics. Capricor…
    STAT · 22d agoRegulatoryNegative↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 22d agoNeutral↗ source
  • Most-wanted fugitive Ronald Fischer operated under alias in biotech industry for two decades
    A Rhode Island man on the most-wanted list was recently uncovered as a hidden employee in the biotech sector, having worked under a false identity for about twenty years. The individual, identifie…
    STAT · 22d agoNegative↗ source