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26 stories matching this filter · ← front page

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STAT1155Endpoints871BioPharma Dive339BioSpace293Fierce Biotech275onclive165raps104globenewswire health73
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allOncology7275Rare Disease1816Cardiology1639Immunology1443Hematology1290Vaccines1172Pulmonology1080
  • 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 · 3d 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 · 5d agoDealPositive↗ source
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fda recalls67
fda medwatch59
fda press38
Psychiatry & CNS856
Ophthalmology488
Pain463
Endocrinology & Metabolism457
Infectious Disease436
  • 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 · 5d 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 · 10d 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 · 10d 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 · 11d 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 · 12d 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 · 17d agoNeutral↗ 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 · 18d 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 · 19d 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 · 24d 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 · 25d 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 · 26d 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
  • 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
  • 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
  • Tango to launch Phase 3 trial in pancreatic cancer after promising combo results
    Tango announced plans to begin a Phase 3 trial testing a combination therapy for pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting, where…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • J&J to acquire Firefly Bio for $1 billion, boosting its KRAS-focused antibody-degrader program
    Johnson & Johnson announced it will purchase Firefly Bio, a preclinical biotech, for $1 billion in cash. Firefly Bio is developing degrader antibody conjugates that aim to target KRAS-driven cance…
    Endpoints · 3mo agoDealPositive↗ source
  • Daiichi eyes almost $15B in oncology sales by 2030 in ADC franchise push
    Daiichi Sankyo is betting on its oncology franchise to push it past 3 trillion Japanese yen ($19 billion) in 2030 revenues. The drugmaker published a new five-year business plan on Monday ...
    Endpoints · 3mo ago↗ source
  • FDA's oncology advisors vote against 'new paradigm' in AstraZeneca trial
    In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn't show a “clinic…
    Endpoints · 4mo ago↗ source
  • FDA, AstraZeneca prep for oncology adcomm
    The FDA is set to convene its first advisory meeting of oncology experts in about nine months, with a couple of AstraZeneca drugs as the focus of the discussion. Details about the meeting of the ...
    Endpoints · 4mo ago↗ source