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151 stories matching this filter · ← front page

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  • 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 · 1d agoLayoffsNegative↗ source
  • FDA shelves Commissioner’s National Priority Voucher program ahead of Heidi Overton confirmation vote
    The Food and Drug Administration has halted the Commissioner’s National Priority Voucher (CNPV) program as the Senate prepares to vote on Heidi Overton’s nomination as the agency’s next commissione…
    BioSpace · 2d agoRegulatoryNeutral↗ source
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  • AstraZeneca acquires Omniose to boost conjugate vaccine platform as FDA flags vision-loss risk for GLP-1 drugs
    AstraZeneca announced it has acquired vaccine startup Omniose, though the financial terms were not disclosed. The purchase gives AstraZeneca access to Omniose's bioconjugation technology, a method…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Amneal and BridgeBio top BioSpace 2027 Best Places to Work list
    BioSpace released its 2027 Best Places to Work list, recognizing 50 life‑science employers with U.S. operations. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, took the top spot among l…
    BioSpace · 4d agoPositive↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 4d agoApprovalPositive↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 8d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 8d agoEarningsPositive↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 8d agoApprovalPositive↗ source
  • Big pharma Q3 earnings roll out as FDA launches rare-disease initiative and uniQure's Huntington's gene therapy enters review
    Over the past week, a dozen major pharmaceutical companies reported third‑quarter results, including AstraZeneca, Biogen, GSK, Bristol Myers Squibb, Merck, Sanofi, AbbVie and Regeneron. Pfizer pos…
    BioSpace · 10d agoEarningsNeutral↗ source
  • Analysts predict biopharma gains as Democrats take Congress control
    Analysts say the biopharma sector is set to benefit from the recent shift in U.S. Congress, with Democrats now holding majorities in both the House and Senate. They note that drug‑pricing debates…
    BioPharma Dive · 10d agoPositive↗ source
  • Pfizer targets Europe first for upcoming Lyme disease vaccine amid rising US cases
    Pfizer is planning to launch its Lyme disease vaccine in Europe first, leveraging its existing tick-borne encephalitis franchise in the region. The vaccine, developed with French partner Valneva,…
    BioSpace · 10d agoRegulatoryPositive↗ source
  • Pfizer reports flat Q3 revenue as non-COVID sales rise 7% and acquired products grow 32%
    Pfizer posted third‑quarter revenue of $16.6 billion, essentially unchanged from $16.7 billion a year earlier. The flat top line reflects declines in its legacy Prevnar vaccine and COVID‑related pr…
    BioSpace · 11d agoEarningsNeutral↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 12d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 14d agoApprovalPositive↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 17d agoPositive↗ source
  • GSK vaccine sales miss expectations amid falling demand from adults
    With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product.
    BioSpace · 17d agoRegulatoryNeutral↗ source
  • Merck and Moderna's mRNA melanoma vaccine shows 42% risk reduction in Phase 3 trial, easing analyst concerns
    At the European Society of Medical Oncology meeting, Merck and Moderna presented data from their Phase 3 INTerpath-001 trial of a personalized mRNA vaccine combined with Keytruda in resected melano…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • US proposes new biotech investment limits on China, but licensing deals remain allowed
    The U.S. Treasury announced a proposal to curb outbound investments in Chinese biotechnology, citing national‑security concerns. The plan would limit U.S. persons from funding certain bio‑derived c…
    BioSpace · 22d agoRegulatoryNeutral↗ source
  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 22d agoPositive readoutNeutral↗ source
  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 22d agoNegative readoutNegative↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 23d agoRegulatoryPositive↗ source
  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 24d agoApprovalPositive↗ source
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 24d agoApprovalPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 25d agoApprovalPositive↗ source
  • FDA releases final guidance on prescription-drug companion apps and software
    FDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
    fda press · 25d agoRegulatoryNeutral↗ source