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  • Novartis' experimental heart drug pelacarsen fails pivotal Phase 3 trial
    Novartis announced that its experimental cardiovascular therapy, pelacarsen, did not meet its primary endpoints in the Phase 3 HORIZON trial. The study compared the drug to placebo and found no red…
    STAT · 7d agoNegative readoutNegative↗ source
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 7d agoApprovalPositive↗ source
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  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 7d agoApprovalPositive↗ source
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • Licensing deals with Chinese biotech stay strong as big pharma pours $550M+ into cancer and obesity pipelines
    Western drug developers continue to sign licensing agreements with Chinese biotechnology firms at a steady pace, according to recent data visualizations. More than 100 such deals have been announc…
    BioPharma Dive · 7d agoDealNeutral↗ source
  • FDA issues guidance to prevent newborn nutrition supply gap
    The U.S. Food and Drug Administration announced it is taking action to address a potential supply gap of neonatal starter parenteral nutrition, which provides essential IV nutrients to premature an…
    fda press · 7d agoRegulatoryPositive↗ source
  • Experts say Angelman syndrome drug failure leaves hope for similar antisense therapies
    Ultragenyx announced that its late-stage trial of an experimental Angelman syndrome drug did not meet its primary endpoints, marking a setback for the rare-disease community. Researchers such as M…
    STAT · 7d agoNegative readoutNeutral↗ source
  • Bristol Myers Squibb pauses autoimmune CAR‑T trials after life‑threatening side effects
    Bristol Myers Squibb announced in early June that it is pausing its CAR‑T therapy trials targeting autoimmune diseases after the trials reported life‑threatening side effects. The company informed…
    STAT · 7d agoRegulatoryNegative↗ source
  • Mass General Brigham drops Dana-Farber from its Medicare Advantage network starting Oct 1
    Mass General Brigham announced that its Medicare Advantage plan will no longer include Dana-Farber Cancer Institute in its provider network beginning October 1, following a recent split between the…
    STAT · 7d agoRegulatoryNegative↗ source
  • FDA revisits botanical drug pathway amid ongoing challenges for clozapine and pig kidney research
    The Food and Drug Administration is taking another look at the regulatory pathway for botanical drugs, signaling renewed interest in how plant‑derived therapies can be evaluated and approved. At t…
    STAT · 7d agoRegulatoryNeutral↗ source
  • Disabled workers face higher risk of losing health insurance, report highlights systemic gaps
    The Morning Rounds newsletter reports that disabled employees are more likely to lose their health coverage, underscoring a systemic vulnerability in the U.S. health insurance landscape. The artic…
    STAT · 7d agoNegative↗ source
  • Lindsay Clancy case highlights risks of fragmented US health care system
    In the months leading up to the tragic deaths of her three children, Lindsay Clancy sought help for worsening mental health from multiple clinicians and two hospitals. She received 13 different med…
    STAT · 7d agoNegative↗ source
  • FDA lifts clozapine monitoring requirements, easing use for children with schizophrenia
    The Food and Drug Administration on Feb. 24, 2025 eliminated the long‑standing monitoring program that has governed clozapine for more than three decades. The change removes the extensive paperwork…
    STAT · 7d agoRegulatoryNeutral↗ source
  • CDC-Pennsylvania dispute over measles death counts fuels drama amid rising cases
    Former CDC officials warn that a clash with Pennsylvania over how measles deaths are counted is creating unnecessary drama while cases surge. They explain that states normally follow a standardize…
    STAT · 7d agoRegulatoryNegative↗ source
  • FDA approves Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 8d agoApprovalPositive↗ source
  • Scaling CAR-T: The hidden challenge of thousands of patient-specific manufacturing runs
    Legend Biotech and Johnson & Johnson’s Carvykti therapy illustrates the personal connection patients have with CAR-T, but also its unique operating model where each commercial dose is linked to an…
    BioPharma Dive · 8d agoNeutral↗ source
  • Gene-edited pig kidneys enable patients to go months without dialysis before receiving human transplants
    Doctors at eGenesis reported that two patients who received genetically engineered pig kidneys were later able to receive human donor kidneys after a period on dialysis. The transition was not seam…
    STAT · 8d agoPositive↗ source
  • Ionis secures FDA approval for Zanvastro, first disease-modifying therapy for rare Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Zanvastro, marking the first disease-modifying treatment for Alexander disease, a rare and often fatal neurol…
    STAT · 8d agoApprovalPositive↗ source
  • Ultragenyx to consider major cost cuts after Angelman drug fails trial
    Ultragenyx announced that its experimental therapy GTX-102 (apazunersen) for Angelman syndrome failed to meet primary and secondary endpoints in a Phase 3 study. The company said there were no dif…
    BioPharma Dive · 8d agoNegative readoutNegative↗ source
  • Superluminal Medicines raises $60 million to advance AI-designed MC4R drug for rare obesity forms
    Superluminal Medicines, an AI-driven drug discovery startup, announced a $60 million financing round aimed at moving its first candidate toward clinical testing. The candidate targets the MC4R G p…
    BioPharma Dive · 8d agoDealPositive↗ source
  • GSK to spend up to $1.3 billion on Hutchmed's dual-target cancer therapy
    GSK announced a deal to acquire the majority rights to Hutchmed's experimental therapy HMPL-A830. The agreement includes an upfront payment of $110 million and potential milestone and royalty payme…
    BioPharma Dive · 8d agoDealNeutral↗ source
  • Seattle researchers unveil $95 million AI biology initiative to map nature’s design rules
    Seattle scientists have announced a new $95 million effort that uses artificial intelligence to decode the design principles of biological molecules. The project, led by Nobel laureate David Baker,…
    STAT · 8d agoDealNeutral↗ source
  • Ultragenyx gene therapy for Angelman syndrome fails Phase 3 trial, company to cut expenses
    An experimental gene therapy targeting Angelman syndrome did not meet its primary endpoint in a Phase 3 study, according to Ultragenyx. The trial showed no difference between the therapy, GTX-102,…
    STAT · 8d agoNegative readoutNegative↗ source
  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • FDA requests public input to accelerate botanical drug product development
    The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward. Botanical drug products are derived from pl…
    fda press · 8d agoRegulatoryNeutral↗ source