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53 stories matching this filter · ← front page

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  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 6h agoApprovalPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 8h agoPositive↗ source
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fda recalls56
fda medwatch50
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Psychiatry & CNS767
Ophthalmology459
Pain428
Endocrinology & Metabolism404
Infectious Disease384
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 2d agoApprovalPositive↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 2d agoLayoffsNegative↗ source
  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 8d agoRegulatoryPositive↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 8d agoPositive↗ source
  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 9d agoDealNeutral↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 9d agoDealPositive↗ source
  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 10d agoPositive readoutPositive↗ source
  • Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%
    Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…
    BioPharma Dive · 15d agoPositive readoutPositive↗ source
  • Infinimmune secures $75 million Series A to develop longer-lasting eczema antibody therapies
    Infinimmune, a biotech based in Alameda, California, announced on Tuesday that it has closed a $75 million Series A financing round. The capital will support the development of its first two clinic…
    BioPharma Dive · 16d agoDealPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 16d agoDealPositive↗ 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 · 21d agoApprovalPositive↗ source
  • Tarsus to acquire eye-drug startup Alkeus in up to $800 million deal
    Tarsus Pharmaceuticals announced Thursday that it will buy Alkeus Pharmaceuticals for up to $800 million, consisting of $270 million in cash and $180 million in stock. The agreement also provides…
    BioPharma Dive · 21d agoDealPositive↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund antibody-drug research for skin and inflammatory diseases
    Attovia Therapeutics completed an IPO raising $289 million, selling 17 million shares at $17 each and valuing the company at $767 million. Shares will begin trading on Nasdaq under the ticker ATTO.…
    BioPharma Dive · 22d agoDealPositive↗ source
  • Merck’s anti‑TL1A antibody tulisokibart fails Phase 2b in systemic sclerosis lung disease but succeeds in hidradenitis suppurativa
    Merck reported mixed Phase 2b results for its anti‑TL1A monoclonal antibody tulisokibart, acquired in the 2023 Prometheus Biosciences purchase. In patients with systemic sclerosis‑associated inter…
    BioSpace · 23d agoNegative readoutNeutral↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 23d agoNegative↗ 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 · 25d 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 · 25d 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 · 25d agoRegulatoryNeutral↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 27d agoNeutral↗ source
  • BMS beats Q2 forecasts and lifts 2026 outlook despite delays in Cobenfy and milvexian data
    BMS reported second‑quarter revenue of $12.97 billion, topping analysts' estimate of $11.73 billion, and earnings per share of $2.04, well above the $1.60 consensus. The strong results prompted the…
    BioSpace · 28d agoEarningsNeutral↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 29d agoEarningsPositive↗ source
  • Biopharma job postings in New York rise 34% over past year, seven companies now hiring
    Biopharma employment opportunities in New York appear to be expanding, with job listings on BioSpace increasing 34% between July 2025 and July 2026. Although the number of postings dipped slightly…
    BioSpace · 29d agoNeutral↗ source
  • Oncology experience not always required for pharma jobs, recruiters say
    Two recruiters say that while oncology experience can help, it is not the sole factor biopharma companies consider when hiring for oncology roles. They note that business stage, relationships and s…
    BioSpace · 29d agoNeutral↗ source