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138 stories matching this filter · ← front page

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  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 1d agoNegative↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 4d agoRegulatoryNeutral↗ source
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  • Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter
    July 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of…
    fda recalls · 7d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 11d ago↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more fi…
    raps · 11d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs tha…
    raps · 11d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 15d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…
    raps · 15d ago↗ source
  • Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
    Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…
    raps · 17d ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
    The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
    fda press · 2mo ago↗ 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 · 2mo ago↗ source
  • Dr Hafron on a Multidisciplinary Quality Initiative Designed to Mitigate the AEs of ADT in Prostate Cancer
    Jason Hafron, MD, discusses findings from a study that evaluated the implementation of a multidisciplinary quality initiative in prostate cancer.
    onclive · 2mo ago↗ source
  • FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer
    The FDA approved trastuzumab deruxtecan for the adjuvant and neoadjuvant treatment of select early-stage HER2-positive breast cancer.
    onclive · 2mo ago↗ source
  • Dr Garzotto on Aglatimagene Besadenovec Plus Valacyclovir and EBRT in Localized Prostate Cancer
    Mark Garzotto, MD, discusses efficacy data with aglatimagene besadenovec plus valacyclovir and EBRT in localized prostate cancer.
    onclive · 2mo ago↗ source
  • Dr Hafron on the FDA Approval of Adjuvant Atezolizumab in MRD+ MIBC
    Jason Hafron, MD, discusses the significance of the FDA approval of adjuvant atezolizumab for MRD+ muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source
  • Durvalumab Plus BCG Reduces High-Risk NMIBC Recurrence or Death Risk by 32% in Phase 3 POTOMAC Trial
    Durvalumab plus BCG induction and maintenance yielded an HR of 0.68 vs BCG alone for DFS in BCG-naive, high-risk non–muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source
  • Darolutamide Plus ADT Yields Significant OS Benefit in mHSPC
    Darolutamide plus ADT demonstrated a 50% reduction in the risk of death in metastatic hormone-sensitive prostate cancer.
    onclive · 2mo ago↗ source
  • OncLive Weekly News Quiz (5/15/2026): Did You Catch 3 New FDA Oncology Approvals?
    Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.
    onclive · 2mo ago↗ source
  • Pembrolizumab Plus BCG Elicits 92% CR Rate in BCG-Naive Very High-Risk T1 NMIBC
    Pembrolizumab plus BCG achieved a 92% 6-month complete response rate in very high-risk T1 bladder cancer with no progression to muscle-invasive disease.
    onclive · 2mo ago↗ source
  • FDA Approves Adjuvant Atezolizumab for MRD+ Muscle-Invasive Bladder Cancer
    The FDA approved adjuvant atezolizumab for muscle-invasive bladder cancer with circulating tumor DNA molecular residual disease.
    onclive · 2mo ago↗ source
  • Roswell Park Team Members Take Part in Global Conference Dedicated to Indigenous Peoples and Cancer
    Members of Roswell Park Comprehensive Cancer Center participated in the 2026 World Indigenous Cancer Conference.
    onclive · 2mo ago↗ source
  • Poll Findings Highlight the Most Anticipated GU Cancer Abstracts at ASCO 2026
    GU experts identified key abstracts of interest from the upcoming ASCO Annual Meeting via OncLive’s social media.
    onclive · 2mo ago↗ source
  • OncLive Polls Reveal Picks for Top GI Cancer Abstracts, Areas of Interest at ASCO 2026
    Polls highlighted key abstracts of interest from the upcoming ASCO Annual Meeting.
    onclive · 2mo ago↗ source