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33 stories matching this filter · ← front page

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  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 4d agoDealPositive↗ source
  • Roche signs $1.53 billion licensing deal with Simcere for preclinical B-cell antibody
    Roche announced a licensing agreement with China's Simcere Zaiming, paying $75 million upfront and potentially up to $1.53 billion in total, for worldwide rights to a preclinical trispecific antibo…
    Fierce Biotech · 6d agoDealPositive↗ source
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73
fda recalls67
fda medwatch60
fda press38
1084
Psychiatry & CNS858
Ophthalmology491
Pain468
Endocrinology & Metabolism465
Infectious Disease437
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 6d agoNegative↗ source
  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 11d agoCRLPositive↗ source
  • Moderna to raise $2 billion via convertible senior notes to fund oncology expansion and reduce debt
    Moderna announced it will issue $2 billion of convertible senior notes. The company says the financing will give it flexibility to invest in its growing oncology portfolio and to repay existing deb…
    Endpoints · 11d agoDealNeutral↗ source
  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 12d agoApprovalPositive↗ source
  • McKesson to acquire Precision Medicine Group for $2.25 billion, boosting oncology capabilities
    McKesson, a Fortune 500 healthcare wholesaler, announced a $2.25 billion acquisition of privately held Precision Medicine Group. The deal will fold Precision into McKesson's oncology and multispec…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 18d agoNeutral↗ source
  • Moderna and Merck report success for personalized mRNA vaccine in late-stage melanoma trial
    Moderna and Merck announced that their personalized mRNA cancer vaccine succeeded in a late-stage melanoma study. The vaccine, called intismeran, was evaluated in a randomized Phase 3 trial, the fi…
    STAT · 19d agoPositive readoutPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck & Co. has entered a collaboration with the Sarah Cannon Research Institute to expand patient access to oncology trials at community sites across the United States. The partnership will use S…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck and Sarah Cannon Research Institute announced a collaboration to improve patient access to oncology trials at community sites across the United States. The partnership will use SCRI’s Accele…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 25d agoPositive readoutPositive↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 26d agoPositive↗ source
  • Aura Biosciences cuts 20% of staff and reshuffles C-suite to focus on ocular oncology
    Aura Biosciences announced it is eliminating about one-fifth of its workforce as part of a broader restructuring under its new chief executive officer, Natalie Holles, who took the helm in April.…
    Fierce Biotech · 27d agoLayoffsNeutral↗ source
  • Pathos AI acquires bispecific ADC from Alphamab and secures AstraZeneca partnership
    Pathos AI announced it will pay $125 million upfront for the rights to JSKN016, a bispecific TROP2/HER3 antibody‑drug conjugate from China’s Alphamab Oncology. The agreement also includes up to $2.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Merck to test experimental sac-TMT antibody-drug conjugate with Keytruda in lung cancer trial
    Merck announced it will start a clinical trial testing its experimental antibody-drug conjugate sac-TMT together with the immunotherapy Keytruda in patients with lung cancer. The study will assess…
    Endpoints · 1mo agoNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 1mo agoNegative↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Tempus acquires Personalis for $1.5 billion to expand cancer genomics and MRD testing
    Tempus announced it will purchase Personalis in a transaction valued at $1.5 billion, giving it full ownership of the cancer‑genomics firm. The deal builds on a 2023 partnership where Tempus inves…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 1mo agoRegulatoryNeutral↗ source
  • San Diego biotech BlossomHill files for IPO to fund EGFR lung-cancer drug program
    BlossomHill Therapeutics, a San Diego oncology biotech focused on small‑molecule drugs, has filed an S‑1 registration statement to become a public company. The company, founded in February 2024 by…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEO
    The U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • J&J EVP John Reed Discusses R&D Model, Oncology Deals and Pipeline Growth Potential
    John Reed, executive vice president of Innovative Medicine at Johnson & Johnson, brings more than a decade of experience overseeing drug pipelines at three of the world’s largest pharmaceutical com…
    Endpoints · 2mo agoNeutral↗ source
  • Oncologists Find Deep Joy in Delivering Hope to Patients and Families
    Khushali Jhaveri, a lymphoma specialist at Indiana University, shares a personal view of what makes oncology rewarding. She recounts a recent encounter with a patient who had endured multiple trans…
    STAT · 2mo agoPositive↗ source