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137 stories matching this filter · ← front page

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  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 2h agoPositive↗ 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 · 16h agoLayoffsNegative↗ source
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  • Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars
    The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
    BioSpace · 1d agoDealNeutral↗ source
  • EyePoint’s Phase 3 trial of duravyu fails to outperform aflibercept, shares plunge 70%
    EyePoint announced that its Phase 3 Lugano trial of the investigational tyrosine kinase inhibitor duravyu did not meet the primary efficacy endpoint when compared with the standard‑of‑care anti‑VEG…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca announced it is stopping a Phase 3 study of its bispecific antibody volrustomig in metastatic non-small cell lung cancer after an interim analysis showed the drug is unlikely to meet it…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca said it is ending its Phase 3 eVOLVE-Lung02 trial that evaluated the bispecific antibody volrustomig combined with chemotherapy as a first-line option for metastatic non-small cell lung…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Merck KGaA's US research site to cut 20 jobs amid broader R&D downsizing
    Merck KGaA's North American division, EMD Serono, announced it will lay off 20 employees at its Billerica, Massachusetts research site. The cuts are slated to take effect in the second half of Oct…
    Fierce Biotech · 2d agoLayoffsNegative↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 5d agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales
    The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…
    BioSpace · 5d agoApprovalNeutral↗ source
  • Two undisclosed gene-therapy deaths raise doubts about China's fast-track trial pathway
    Two recent deaths in China’s early‑stage gene‑therapy trials have drawn international attention. Both patients suffered severe immune reactions after receiving high‑dose viral vector treatments, an…
    Fierce Biotech · 5d agoRegulatoryNegative↗ source
  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 5d agoRegulatoryPositive↗ source
  • Versa Vascular appoints former Medtronic heart franchise leader Bill Shields as CEO
    Bill Shields, who spent 15 years leading Medtronic’s structural heart franchise, is leaving the medtech giant to become chief executive of Versa Vascular, a startup developing tricuspid valve repai…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Seven deaths linked to Neurocrine’s Prader-Willi drug Vykat raise safety concerns
    Clinicians have warned that seven patients who received Neurocrine Biosciences' recently approved Prader-Willi syndrome therapy Vykat have died, prompting a new safety alert for the patient communi…
    BioSpace · 7d agoRegulatoryNegative↗ source
  • BridgeBio’s ATTR drug Attruby posts strong Q2 sales surge as Alnylam trims Amvuttra outlook
    BridgeBio Pharma reported that its transthyretin amyloidosis treatment Attruby generated $222.4 million in second‑quarter sales, more than triple the $71.5 million earned in the same period a year…
    BioSpace · 7d agoEarningsPositive↗ source
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 7d agoApprovalPositive↗ 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 · 8d agoDealPositive↗ source
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 9d agoDealPositive↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 9d agoNegative readoutNegative↗ source
  • BMS commits $2.3 billion to build modular manufacturing campus in Houston, creating 2,500 jobs
    Bristol Myers Squibb announced a $2.3 billion investment to construct a new manufacturing campus in Houston, Texas. The site will cover about 600,000 square feet and is designed to be modular, allo…
    BioSpace · 9d agoPositive↗ source
  • BioMarin drops BMN 401 after Phase 3 trial misses clinical endpoints, ending $270M Inozyme asset
    BioMarin announced it will stop development of BMN 401, an enzyme replacement therapy acquired in its $270 million purchase of Inozyme Pharma. The decision follows the Phase 3 ENERGY trial in pati…
    BioSpace · 9d agoNegative readoutNegative↗ 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 · 10d agoCRLNeutral↗ 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 · 12d agoRegulatoryNeutral↗ source
  • LifeMine Therapeutics secures $263 million in dual venture rounds to advance organ transplant aftercare drug
    LifeMine Therapeutics announced it has raised a total of $263 million through a $75 million Series D and an $188 million Series F round, opting for private financing rather than an IPO. The capita…
    BioSpace · 13d agoDealPositive↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 13d agoDealPositive↗ source