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334 stories matching this filter · ← front page

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  • Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update
    Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
    Fierce Biotech · 12d ago↗ source
  • Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial
    A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.<br>
    Fierce Biotech · 12d ago↗ source
  • Spurred by deep cuts and M&A activity, H1 layoffs could oust 14,000+ in biopharma
    Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac.
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BioSpace · 12d ago↗ source
  • Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 12d ago↗ source
  • Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile products
    <p>The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.</p>
    raps · 12d ago↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    <p>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…
    raps · 12d ago↗ source
  • Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives
    <p>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 a…
    raps · 12d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 12d ago↗ source
  • Nobel Laureate Jennifer Doudna enters AI protein design arena
    Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered pro…
    Fierce Biotech · 12d ago↗ source
  • Why early de-risking is redefining the path to IND
    Lonza explains why early de-risking has become a strategic imperative for biotech teams working to reach IND with confidence.
    Fierce Biotech · 13d ago↗ source
  • Understanding Agentic AI in Clinical Development
    Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but becaus…
    Fierce Biotech · 13d ago↗ source
  • Kelun’s Merck-partnered ADC notches late-stage NSCLC win alongside Keytruda
    The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Par…
    BioSpace · 13d ago↗ source
  • Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs
    When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for th…
    Fierce Biotech · 13d ago↗ source
  • Diamantas backtracks on Makary’s policies issued in journal articles
    <p>The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official…
    raps · 13d ago↗ source
  • BIO San Diego 2026 Executive Interviews
    Every year, the BIO International Convention brings together more than 20,000 leaders from across the global life sciences ecosystem.
    Fierce Biotech · 13d ago↗ source
  • Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
    <p>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 indust…
    raps · 14d ago↗ source
  • Building a workforce engine for biomanufacturing
    Ohio’s $30M training initiative aims to scale talent pipelines and power life sciences growth statewide.
    Fierce Biotech · 15d ago↗ source
  • De-Risking a Rare Disease Launch Starts with Precision
    Why traditional models fall short in rare disease commercialization—and what works instead.
    Fierce Biotech · 1mo ago↗ source
  • <![CDATA[Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC]]>
    <![CDATA[Joshua J. Meeks, MD, PhD, discusses data from a real-world study of BCG retreatment after BCG failure in NMIBC.]]>
    onclive · 2mo ago↗ source
  • <![CDATA[Dr Hafron on a Multidisciplinary Quality Initiative Designed to Mitigate the AEs of ADT in Prostate Cancer]]>
    <![CDATA[Jason Hafron, MD, discusses findings from a study that evaluated the implementation of a multidisciplinary quality initiative in prostate cancer.]]>
    onclive · 2mo ago↗ source
  • <![CDATA[Preoperative Intravesical Mitomycin-C Before TURBT Cuts Recurrence Risk by 77% in NMIBC Over 5 Years]]>
    <![CDATA[Two doses of intravesical mitomycin-C administered before TURBT produced a 77% reduction in the risk of recurrence or death vs TURBT alone in NMIBC.]]>
    onclive · 2mo ago↗ source
  • <![CDATA[Genomic Disease Burden Markers, PD-L1 Expression Predictive of pOR With Neoadjuvant Gem-iDRS ± Cetrelimab in MIBC]]>
    <![CDATA[A biomarker analysis of SunRISe-4 found that high baseline TMB, GBD, and PD-L1 expression were associated with pathologic overall response to the regimen. ]]>
    onclive · 2mo ago↗ source
  • <![CDATA[Dr Croll on Radiographic Size Change vs irRVT After Neoadjuvant Therapy in RCC]]>
    <![CDATA[Benjamin Croll, MD, discusses findings from a study of the correlation between radiographic response and pathologic response in RCC.]]>
    onclive · 2mo ago↗ source
  • <![CDATA[FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer]]>
    <![CDATA[The FDA approved trastuzumab deruxtecan for the adjuvant and neoadjuvant treatment of select early-stage HER2-positive breast cancer.]]>
    onclive · 2mo ago↗ source
  • <![CDATA[Dr Garzotto on Aglatimagene Besadenovec Plus Valacyclovir and EBRT in Localized Prostate Cancer]]>
    <![CDATA[Mark Garzotto, MD, discusses efficacy data with aglatimagene besadenovec plus valacyclovir and EBRT in localized prostate cancer.]]>
    onclive · 2mo ago↗ source