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53 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's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
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fda recalls48
fda medwatch41
fda press28
911
Psychiatry & CNS725
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease362
  • 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
  • Skye Bioscience and Redx Pharma combine to form Fibrx Therapeutics with $125M financing for fibrosis pipeline
    Skye Bioscience announced a combination with privately held Redx Pharma, creating a new public company called Fibrx Therapeutics. The transaction is structured as a reverse merger and provides $12…
    Fierce Biotech · 8d agoDealPositive↗ source
  • 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
  • Deerfield-backed Boulevard Bio raises $65 million and unveils three autoimmune drug candidates
    Boulevard Bio, a New York‑based biotech focused on B‑cell biology, announced it has emerged from stealth with $65 million in financing from Deerfield Management. The funding supports the developmen…
    Fierce Biotech · 11d agoDealPositive↗ source
  • BioMarin halts development of BMN 401 after phase 3 miss
    BioMarin Pharmaceutical announced it is ending all work on its experimental enzyme replacement therapy BMN 401 following a late‑stage trial that did not meet one of two primary goals in patients wi…
    Fierce Biotech · 15d agoNegative readoutNegative↗ 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
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • LifeMine Therapeutics secures $188 million Series E funding from Gates, Bezos and others
    LifeMine Therapeutics, a Massachusetts biotech, recently completed a $188 million Series E round, attracting billionaire investors Bill Gates and Jeff Bezos. The funding follows a $75 million Seri…
    Fierce Biotech · 17d 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
  • Otsuka's Voyxact hits key secondary endpoint in Phase 3 IgA nephropathy trial as BioNTech cuts revenue outlook
    Otsuka announced that its experimental kidney drug Voyxact met a key secondary endpoint in the Phase 3 VISIONARY study of patients with IgA nephropathy. The positive result suggests the therapy ha…
    Endpoints · 18d agoPositive readoutNeutral↗ 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
  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 24d agoDealNeutral↗ 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
  • 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
  • Kolon’s cell-based gene therapy misses key endpoints in phase 3 osteoarthritis trial
    Kolon TissueGene reported that its phase 3 study of TG‑C, a cell‑based gene therapy for knee osteoarthritis, failed to meet its co‑primary endpoints. Patients receiving the therapy showed no statis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Dimerix acquires Mission's phase-2 ready AKI drug in $292 million deal
    Dimerix announced it has acquired the acute kidney injury candidate MTX652 from Mission Therapeutics in a deal valued at up to $292 million, including a $5 million upfront payment. Mission had com…
    Fierce Biotech · 1mo agoDealPositive↗ 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
  • Jasper Therapeutics merges with Kira Pharmaceuticals, divests Tavneos rival to Mirador
    Jasper Therapeutics announced a merger with Nasdaq‑listed Kira Pharmaceuticals, positioning the combined company for a fresh strategic direction. The deal follows a difficult period for Jasper, whi…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 1mo agoDealPositive↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ source
  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 1mo agoApprovalPositive↗ 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