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  • U.S. policy bars Ebola patients from entering country, plans overseas evacuation
    U.S. health officials announced that any American who contracts Ebola will not be taken to the United States for care. Instead, patients will be moved to undisclosed locations in Europe for treatme…
    STAT · 3mo agoRegulatoryNegative↗ source
  • FDA delays AstraZeneca breast cancer drug camizestrant PDUFA date
    The U.S. Food and Drug Administration has extended the PDUFA target date for AstraZeneca’s breast cancer candidate camizestrant, pushing the review timeline back by a few days. No new deadline was…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
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  • 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 · 3mo 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 · 3mo agoDealPositive↗ source
  • Relay Therapeutics' zovegalisib shows 60% response in mid‑stage trial for rare vascular anomalies
    Relay Therapeutics reported early data from a phase 2 trial of its experimental drug zovegalisib in patients with vascular anomalies, a group of rare disorders characterized by abnormal blood vesse…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Relay Therapeutics' zovegalisib meets efficacy endpoint in Phase 2 vascular anomalies trial
    Relay Therapeutics reported that its PI3Kα inhibitor zovegalisib achieved the predefined efficacy threshold in a Phase 2 study of a rare genetic vascular anomaly. The data readout exceeded Wall Str…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Merck's China-sourced ADC shows survival benefit in Phase 3 endometrial cancer trial
    Merck & Co., in partnership with Chinese biotech Kelun-Biotech, reported that its experimental antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoint in a global Phase 3…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Merck and Kelun-Biotech's ADC sac-TMT secures first global Phase 3 win ahead of schedule
    Merck and China-based Kelun-Biotech reported that their experimental antibody-drug conjugate sac-TMT achieved a positive outcome in a global Phase 3 study, marking the first such success for the ca…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Regeneron signs up to $125 million deal with Parabilis to target difficult drug targets
    Regeneron announced a deal with Parabilis Medicines valued up to $2.2 billion, with an upfront payment of $125 million. The agreement aims to give Regeneron access to Parabilis’s platform that dis…
    Endpoints · 3mo agoDealNeutral↗ source
  • Regeneron's LAG-3 inhibitor fianlimab fails Phase 3 skin cancer trial
    Regeneron announced that its experimental LAG-3 inhibitor fianlimab did not meet its primary endpoint in a late-stage trial for a skin cancer indication. The Phase 3 study was designed to evaluate…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Texas launches clinic to support individuals seeking detransition services
    Texas health officials announced the opening of a clinic dedicated to people who want to reverse a gender transition, marking a new service in the state. The facility will provide counseling, medi…
    STAT · 3mo agoNeutral↗ source
  • Americans in Congo May Have Been Exposed to Ebola; One Shows Possible Symptoms, Tests Pending
    Several Americans traveling in the Democratic Republic of the Congo are believed to have had high risk exposure to suspected Ebola cases, according to sources familiar with the situation. At least…
    STAT · 3mo agoNeutral↗ 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 · 3mo agoNeutral↗ source
  • Preoperative intravesical mitomycin C cuts NMIBC recurrence risk by 77% over five years
    A recent study evaluated giving two doses of intravesical mitomycin C before transurethral resection of bladder tumor (TURBT) in patients with non‑muscle‑invasive bladder cancer (NMIBC). Compared…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Resigns, Prompting Concerns Over Agency Direction
    FDA Commissioner Marty Makary stepped down on Tuesday, leaving the agency without a permanent leader as it already faces turnover in its drug and biologics divisions. Makary had recently appeared…
    STAT · 3mo agoNegative↗ source
  • High TMB, GBD and PD-L1 Levels Linked to Better Response in Neoadjuvant Gem-iDRS or Cetrelimab Trial for Bladder Cancer
    The SunRISe-4 trial evaluated neoadjuvant gemcitabine‑based immunotherapy with or without cetrelimab in patients with muscle‑invasive bladder cancer. A biomarker sub‑analysis showed that patients…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Expert reviews real-world data on BCG retreatment after failure in non-muscle-invasive bladder cancer
    Dr Joshua J. Meeks, MD, PhD, provided an overview of a real-world study that examined the use of BCG retreatment in patients with non‑muscle‑invasive bladder cancer (NMIBC) who had previously faile…
    onclive · 3mo agoNeutral↗ source
  • Multidisciplinary quality program shown to cut side effects of androgen deprivation therapy in prostate cancer
    Dr Hafron discussed a recent study that evaluated a multidisciplinary quality initiative aimed at reducing adverse events linked to androgen deprivation therapy for prostate cancer. The program co…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA approves trastuzumab deruxtecan for early-stage HER2-positive breast cancer
    The U.S. Food and Drug Administration has granted approval for trastuzumab deruxtecan (T‑DXd) as a treatment option in both the adjuvant and neoadjuvant settings for certain patients with early-sta…
    onclive · 3mo agoApprovalPositive↗ source
  • FDA approves adjuvant atezolizumab for MRD-positive muscle-invasive bladder cancer, says Dr. Hafron
    The U.S. Food and Drug Administration has granted approval for adjuvant atezolizumab in patients with MRD-positive muscle-invasive bladder cancer. The decision expands the use of the immunotherapy…
    onclive · 3mo agoApprovalPositive↗ source
  • Durvalumab combined with BCG cuts recurrence risk by 32% in phase 3 trial for high-risk non-muscle-invasive bladder cancer
    A phase 3 study called POTOMAC tested durvalumab together with BCG induction and maintenance against BCG alone in patients who had not previously received BCG and who have high-risk non-muscle-inva…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Darolutamide with ADT cuts death risk by half in metastatic hormone‑sensitive prostate cancer
    A recent study evaluated darolutamide combined with androgen deprivation therapy in patients with metastatic hormone‑sensitive prostate cancer. The trial reported a 50% reduction in the risk of dea…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA approves adjuvant atezolizumab for MRD-positive muscle-invasive bladder cancer
    The U.S. Food and Drug Administration has granted approval for adjuvant atezolizumab in patients with muscle‑invasive bladder cancer who test positive for circulating tumor DNA, indicating molecula…
    onclive · 3mo agoApprovalPositive↗ source