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  • J&J invests $785M in Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson has agreed to pay $785 million up front to Sail Biomedicines, including a $465 million equity infusion and up to $140 million in milestone payments. The agreement also gives J&J a…
    Fierce Biotech · 11h agoDealPositive↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 1h agoRegulatoryNegative↗ source
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  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 2h agoNeutral↗ source
  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 9h agoNegative readoutNegative↗ source
  • Senate health panel confirms Trump picks for CDC director and pandemic preparedness chief
    The Senate health committee approved two Trump administration nominees for key health positions on Thursday. Erica Schwartz was confirmed as CDC director with bipartisan support from all Republica…
    STAT · 29m agoRegulatoryNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 4h agoRegulatoryNeutral↗ source
  • Opinion: Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases
    “The next 10 years of mycetoma care will determine whether it remains a story of neglect or becomes one of collective action,” writes Borna Nyaoke-Anoke.
    STAT · 6h agoRegulatoryNeutral↗ source
  • Experts warn U.S. pharma reliance on China poses national security threat
    The authors of a recent Council on Foreign Relations report argue that the United States’ dependence on China for biopharmaceutical manufacturing creates a clear national security risk. They point…
    STAT · 6h agoNegative↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 6h agoRegulatoryNegative↗ source
  • Federal judge rejects 26 states' bid to delay Medicaid work requirement rollout
    A U.S. District Judge in Massachusetts issued an order Thursday refusing to grant a preliminary injunction that would have paused the new Medicaid work‑requirement rules. The decision leaves the fe…
    STAT · 1h agoRegulatoryNeutral↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 10h agoRegulatoryNegative↗ source
  • STAT+: Rising oil prices can boost the cost of some medicines. One expert says it’s time to lower reliance on fossil fuels
    Unitaid found the rising price of oil could boost the cost of a widely used HIV medicine it reviewed in a detailed analysis.
    STAT · 1h ago↗ source
  • Bristol Myers delays Cobenfy Alzheimer’s psychosis readout again amid another quarterly beat
    Investors awaiting Bristol Myers Squibb’s key Alzheimer’s psychosis readout for Cobenfy and atrial fibrillation data for milvexian will have to wait a little longer.
    Fierce Biotech · 5h ago↗ source
  • Attovia, Braveheart and Vogenx seek more than $500M across trio of IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have set target ranges for their IPOs, positioning the trio to collectively net more than $500 million from public investors.
    Fierce Biotech · 5h ago↗ source
  • Labcorp posts higher Q2 earnings on strength of diagnostics, lab services; adjusts full-year guidance
    Labcorp continues to power along as it posts strong quarterly earnings led by growth in its diagnostics and lab services and triggering the medtech to raise its full-year guidance.
    Fierce Biotech · 6h ago↗ source
  • Takeda scraps another phase 2 celiac disease therapy, narrowing pipeline to one
    Takeda has dropped another celiac disease therapy from its phase 2 pipeline, leaving the company with just one shot at treating the condition.
    Fierce Biotech · 7h ago↗ source
  • GSK pens $110M biological datasets pact with AI biotech Relation
    GSK is boosting its AI chops with a new deal worth up to $110 million with Relation.
    Fierce Biotech · 8h ago↗ source
  • Boston Scientific cuts guidance again after unveiling restructuring plan
    Boston Scientific is cutting its financial guidance for the second quarter in a row as it gears up for a tough six months ahead.
    Fierce Biotech · 10h ago↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 20h agoRegulatoryNegative↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 22h agoApprovalPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 23h agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 17h agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 17h agoNegative readoutNegative↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 17h agoPositive readoutPositive↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 23h agoDealPositive↗ source