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204 stories matching this filter · ← front page

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  • Celiac disease faces new therapeutic possibilities as companies target underlying inflammation
    Celiac disease affects roughly one in every hundred people worldwide, imposing a daily burden that goes far beyond dietary restrictions. Currently, patients have no approved medicines and must rel…
    BioPharma Dive · 3mo agoPositive↗ source
  • FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
    The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin. This is the first OTC…
    fda press · 3mo agoApprovalPositive↗ source
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  • Rapport Therapeutics says it is ready to launch its seizure drug independently
    In a recent interview, CEO Abe Ceesay explained that Rapport Therapeutics has assembled an investor syndicate and feels fully prepared to bring its seizure drug to market on its own. Founded in 20…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • HHS gives measured response to alcohol risk study as health news roundup covers soda link, NIH debate, diabetes apology and DOJ lawsuit
    The Department of Health and Human Services issued a cautious reaction to a recent paper that examined the relationship between alcohol consumption and health risks, noting the need for further evi…
    STAT · 3mo agoNeutral↗ source
  • ADA CEO apologizes for expelling five members over protest literature, vows review and trust rebuilding
    Five members of the American Diabetes Association were removed from its annual scientific sessions in New Orleans after distributing editorial material that criticized federal research funding cuts…
    STAT · 3mo agoNegative↗ source
  • Mass General launches mobile vascular clinic to treat unhoused patients and prevent amputations
    Unhoused individuals often face untreated vascular problems that can quickly lead to severe wounds and the risk of losing a limb. Limited access to regular medical care leaves many without timely i…
    STAT · 3mo agoPositive↗ source
  • Lundbeck advances PACAP-targeting migraine drug after mid-stage trial shows reduction in migraine days
    Lundbeck reported new data from a mid-stage study of its experimental migraine prevention therapy, bocunebart, which targets the PACAP protein involved in headache pathways. The trial enrolled hun…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Cigna to End Coverage of GLP-1 Weight-Loss Drugs Wegovy and Zepbound for Employees Starting July 1
    Cigna announced it will stop covering GLP-1 weight-loss medications for its employee health plan, effective July 1. The decision affects drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepboun…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Croatian researcher’s five-decade quest to uncover BPC-157’s potential draws FDA attention
    In 1975 a second‑year medical student at the University of Zagreb heard a lecture on stress and the stomach lining. He imagined the organ produced a natural anti‑stress chemical and set out to find…
    STAT · 3mo agoNeutral↗ source
  • Revolution Medicines' daraxonrasib nearly doubles survival in pancreatic cancer trial
    Data presented at the American Society of Clinical Oncology meeting showed that Revolution Medicines' experimental drug daraxonrasib significantly extended survival for patients with metastatic pan…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 4mo agoApprovalPositive↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Conflicting guidelines leave women unsure when to start routine mammograms
    Deciding when to begin routine mammograms is confusing because major health groups recommend different starting ages-some say 40, others 45, and a recent recommendation pushes the start to 50. They…
    STAT · 4mo agoNeutral↗ source
  • Pain drug research gains momentum a year after Vertex launch as new startups revive sodium channel targets
    A year after Vertex introduced its breakthrough pain medication, the field of pain drug development is at a pivotal crossroads. Analysts note that renewed scientific focus and investor interest are…
    BioPharma Dive · 4mo agoPositive↗ source
  • Honesty and Humor Offer Hope in Breast Cancer Survivorship, Says Dr Nunnery and Survivor Annie Bond
    The Breast Cancer Briefing podcast, hosted by Dr Sara Nunnery of Tennessee Oncology, featured a conversation with Annie Bond, a breast cancer survivor and patient advocate. Bond, who was first dia…
    onclive · 4mo agoPositive↗ source
  • Dr Randall explains rationale for CSF-1R inhibitor pimicotinib in tenosynovial giant cell tumor trial
    Dr Randall, a professor at UC Davis Comprehensive Cancer Center, discussed the clinical reasoning behind testing the selective CSF-1R inhibitor pimicotinib (ABSK021) for tenosynovial giant cell tum…
    onclive · 4mo agoNeutral↗ source
  • President Trump says government may consider approving certain forms of kratom-derived 7-OH
    President Trump suggested the federal government could move to approve some forms of 7-OH, an opioid derived from the kratom plant. 7-OH, short for 7-hydroxymitragynine, occurs naturally in kratom…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • AI dependence mirrors addiction, warns psychiatrist, sparking debate on hidden costs
    Jonathan Avery, vice chair for addiction psychiatry at Weill Cornell Medicine, reflects on his podcast about addiction and the mixed feedback he receives. In a recent episode he interviewed NYU ne…
    STAT · 4mo agoNeutral↗ source
  • FDA approves zenocutuzumab for previously treated NRG1-fusion cholangiocarcinoma
    The FDA has granted approval for zenocutuzumab to treat patients with previously treated, advanced cholangiocarcinoma that carries an NRG1 fusion. The decision was based on data from the eNRGy stud…
    onclive · 4mo agoApprovalPositive↗ source
  • Pimicotinib shows 76% response rate and functional benefits in TGCT phase 3 trial
    Dr. Randall discussed results from the phase 3 MANEUVER trial of the CSF-1 receptor inhibitor pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The data were presented at the 2025…
    onclive · 4mo agoPositive readoutPositive↗ source
  • FDA approves Zenocutuzumab for NRG1 fusion-positive advanced cholangiocarcinoma
    The U.S. Food and Drug Administration has granted approval for zenocutuzumab-zbco, marketed as Bizengri, to treat adult patients with NRG1 fusion‑positive advanced, unresectable or metastatic chola…
    onclive · 4mo agoApprovalPositive↗ source
  • Phase 3 MANEUVER trial shows pimicotinib improves response and pain in advanced TGCT, supporting FDA NDA acceptance
    The phase 3 MANEUVER study evaluated pimicotinib in patients with advanced diffuse tenosynovial giant cell tumor. The trial compared the oral agent to placebo and collected both clinical and patien…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Vertex Q1 revenue slightly below forecasts as key drug sales miss estimates, but Alyftrek revenue surges
    Vertex Pharmaceuticals reported first‑quarter revenue of about $3 billion, falling just short of Wall Street expectations. The modest miss left the stock largely unchanged on the day of the release…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source