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31 stories matching this filter · ← front page

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  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source
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73
fda recalls48
fda medwatch41
fda press28
911
Psychiatry & CNS727
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease362
  • Boulevard Bio launches with $65 million to develop bispecific antibodies for IgA nephropathy and other autoimmune diseases
    Boulevard Bio, a new biotech co-founded by autoimmune researcher Georg Schett and former Sanofi CSO Frank Nestle, announced its launch on Wednesday with $65 million in funding. The company’s first…
    BioPharma Dive · 10d agoDealPositive↗ source
  • LifeMine secures $263M to advance fungal-derived organ transplant drug
    LifeMine Therapeutics announced it has closed two venture financings that together raised $263 million. The capital will be used to push its experimental therapy, LIFE-001, further along the develo…
    BioPharma Dive · 16d 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 · 17d agoDealPositive↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 22d agoNegative readoutNegative↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Vertex to buy Crinetics for $10 billion, expanding into endocrine disease drugs
    Vertex announced an agreement to acquire Crinetics Pharmaceuticals for $10 billion in cash, paying $85 per share. The purchase brings two recently launched drugs for a rare hormonal disorder into…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
    BioPharma Dive · 1mo ago↗ source
  • Ipsen to buy Swiss biotech Memo Therapeutics in potential $800M deal
    The purchase hands Ipsen an experimental medicine in late-stage testing for a virus that often affects kidney transplant patients.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • AstraZeneca’s ‘extensive’ obesity drug push; $125M for ultrasound-aided genetic medicine
    Newly published data convinced AstraZeneca to conduct a sprawling late-stage program for its GLP-1 pill. Elsewhere, Bausch + Lomb will lay off 119 employees and Cartesian boosted its ‘in vivo’ cell…
    BioPharma Dive · 2mo ago↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 2mo ago↗ source
  • Lilly, Ascidian link up in RNA exon editing pact
    Worth as much as $1.9 billion, the deal directs Ascidian to help Lilly find potential drugs for genetically driven kidney diseases.
    BioPharma Dive · 2mo ago↗ source
  • FDA approves AstraZeneca’s new kind of hypertension drug
    Baxfendy inhibits a blood-pressure-raising enzyme and, according to AstraZeneca executives, is poised to be a “big product” that should ultimately generate $5 billion or more in annual sales.
    BioPharma Dive · 3mo ago↗ source
  • Safety and Toxicity Management in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss practical approaches to monitoring and managing toxicities associated with radiopharmaceutical therapies in metastatic castration-resistant prostate…
    onclive · 3mo ago↗ source
  • Combination and Sequencing Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss ongoing questions surrounding combination approaches and optimal sequencing strategies for radiopharmaceutical therapies in metastatic castration-res…
    onclive · 3mo ago↗ source
  • GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026
    We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.
    onclive · 3mo ago↗ source
  • Dr Silbermann on Clinical Trial Design Considerations in Multiple Myeloma
    Rebecca Silbermann, MD, MMS, outlines key trial design considerations in multiple myeloma, including supportive care measures and end point selection.
    onclive · 3mo ago↗ source
  • Renal Cell Carcinoma: Real-World Factors in First-Line Treatment Selection
    In this segment, Dr. Elizabeth Plimack and Dr. Yasser Ged discuss how real-world patient factors influence first-line treatment decisions in renal cell carcinoma.
    onclive · 3mo ago↗ source
  • Expanding ctDNA Applications to RCC and Germ Cell Tumors
    Experts explain how ctDNA tracking in metastatic cancer guides therapy tweaks, flags relapse early, and where it fails in brain/peritoneal disease.
    onclive · 3mo ago↗ source