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1,622 stories matching this filter · ← front page

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  • Tango Therapeutics reports 82% response rate for PRMT5 inhibitor combo in pancreatic cancer trial
    Tango Therapeutics announced a 14% reduction in its workforce while also presenting new data on its PRMT5 inhibitor combined with Revolution Medicines’ RAS(ON) inhibitor Rasonque at the ESMO 2026 m…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 15d agoDealPositive↗ source
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  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 15d agoNegative readoutNegative↗ source
  • Bristol Myers Squibb partners with Institute for Healthcare Improvement to increase cancer trial participation
    Bristol Myers Squibb has entered a three-year collaboration with the Institute for Healthcare Improvement called the Cancer Collective Action Collaborative. The program will bring together 24 team…
    Fierce Biotech · 15d agoPositive↗ source
  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 15d agoNeutral↗ source
  • BioNTech's HER2-directed ADC shows modest benefit and higher lung toxicity in phase 3 trial
    BioNTech reported results of its phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan (t-pam), an HER2-directed antibody-drug conjugate, in patients with HR-positive, HER2-low metastati…
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 15d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 15d agoApprovalNeutral↗ source
  • Corxel opts for SPAC merger to take oral obesity drug public on Nasdaq
    Corxel Pharmaceuticals, an obesity-focused biotech, said it will merge with Amanat Acquisition in the first half of next year to become a publicly traded company on Nasdaq. The company’s CFO noted…
    Fierce Biotech · 15d agoDealPositive↗ source
  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 15d agoNeutral↗ source
  • Lycia Therapeutics raises $317.5 million in upsized Nasdaq IPO as Windward Bio eyes listing
    Lycia Therapeutics completed an initial public offering on Nasdaq, selling shares that generated roughly $317.5 million after the offering was upsized. The company’s debut on the exchange marks a…
    Fierce Biotech · 15d agoDealPositive↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 15d agoRegulatoryNeutral↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 15d ago↗ source
  • Incyte reports strong early results for KRAS G12D inhibitor in pancreatic cancer, rivals RevMed
    Incyte presented phase 1 data at the European Society for Medical Oncology congress in Madrid, highlighting its KRAS G12D inhibitor INCB161734 combined with chemotherapy for pancreatic ductal adeno…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • J&J touts promising RIPTAC data with 59% PSA reductions in prostate cancer trial
    At the European Society for Medical Oncology (ESMO) 2026 meeting in Madrid, Johnson & Johnson presented early clinical data from its RIPTAC platform, which the company acquired through a $3 billion…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • ESMO: BMS’ Massacesi hails ‘very promising’ data for BioNTech-partnered PD-L1xVEGF-A drug
    Bristol Myers Squibb Chief Medical Officer Cristian Massacesi, M.D., has told Fierce that the latest data for its BioNTech-partnered PD-L1xVEGF-A drug are “very promising,” as phase 3 ambitions ram…
    Fierce Biotech · 16d agoNeutral↗ source
  • Roche reports superior survival for KRAS G12C inhibitor divarasib in phase 3 trial
    Roche presented detailed results from its phase 3 Krascendo 1 trial of the KRAS G12C inhibitor divarasib, comparing it with Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. The open‑label stud…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Merck and Moderna disclose phase 3 cancer vaccine data early after leak, showing improved recurrence-free survival with Keytruda
    Merck & Co. and Moderna were forced to release their phase 3 trial results for the intismeran autogene cancer vaccine two days ahead of schedule after an unexpected leak of the data ahead of the ES…
    Fierce Biotech · 17d agoPositive readoutNeutral↗ source
  • AstraZeneca says phase 3 ADC shows strong overall survival despite missing progression-free survival endpoint
    AstraZeneca executives emphasized that the detailed data from their phase 3 study of the next‑generation antibody‑drug conjugate are robust enough to be presented to regulators, even though the tri…
    Fierce Biotech · 17d agoPositive readoutNeutral↗ source
  • Genmab reports phase 3 success for Elahere competitor and previews Merus buyout data
    Genmab disclosed at the European Society for Medical Oncology meeting that its experimental therapy, positioned as a rival to Elahere, achieved a positive outcome in a phase 3 trial. The result si…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • EQT to acquire Qiagen in €10.8 billion deal
    EQT, a private‑equity firm, announced it will purchase Dutch molecular diagnostics company Qiagen in a transaction valued at €10.8 billion, including €1.1 billion of net debt. The deal follows a f…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Roche's Genentech reports 43% reduction in kidney damage marker in phase 3 IgA nephropathy trial
    Roche Genentech disclosed detailed results from its phase 3 IMAgINATION trial of the antisense oligonucleotide sefaxersen in patients with IgA nephropathy. The trial showed a 43.1% greater reducti…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • Takeda’s ADC arcotatug tavatecan shows survival benefit in phase 3 gastric cancer trial
    Takeda, together with Innovent Biologics, presented results from a late‑stage study of its next‑generation claudin‑18.2 antibody‑drug conjugate, arcotatug tavatecan (also known as IBI343 or TAK‑921…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 18d agoDealPositive↗ source
  • RNAi developers see surge in IPOs and funding as industry interest revives
    BioPharma Dive’s latest data‑visualization series highlights a rapid rise in interest and investment for companies developing RNA interference (RNAi) medicines. After a years‑long lull, more than…
    BioPharma Dive · 18d agoPositive↗ source