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23 stories matching this filter · ← front page

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  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 8d ago↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 16d ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
28
fda recalls22
fda press21
fda medwatch17
570
Vaccines507
Endocrinology & Metabolism288
Ophthalmology255
Infectious Disease251
Pain232
fda press · 29d 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
  • Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
    The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.
    BioPharma Dive · 1mo ago↗ source
  • Biotech SPAC deal gets it to Nasdaq; AstraZeneca Phase 3 win in bone disease
    Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics. 💸 A SPAC!: Talawar Therapeutics will land on the Nasdaq via a combination with blank-check company JATT II Acquisitio…
    Endpoints · 1mo ago↗ source
  • Incyte to buy blood disorder drug in possibly $2B deal
    Acquiring Vega Therapeutics, an offshoot of "hub-and-spoke" biotech Star Therapeutics, would give Incyte a medicine that’s in late-stage testing and designed to control bleeding.
    BioPharma Dive · 1mo ago↗ source
  • Safety and Toxicity Management in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss practical approaches to monitoring and managing toxicities associated with radiopharmaceutical therapies in metastatic castration-resistant prostate…
    onclive · 2mo ago↗ source
  • Combination and Sequencing Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss ongoing questions surrounding combination approaches and optimal sequencing strategies for radiopharmaceutical therapies in metastatic castration-res…
    onclive · 2mo ago↗ source
  • Patient Selection for Radiopharmaceuticals in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss how patient selection and disease characteristics influence the use of radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC).
    onclive · 2mo ago↗ source
  • Alpha-Emitting Therapies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss the evolving role of alpha-emitting radiopharmaceutical therapies in metastatic castration-resistant prostate cancer (mCRPC), with a focus on radium…
    onclive · 2mo ago↗ source
  • Combination Radiopharmaceutical Approaches in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss emerging combination strategies involving radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC), with a focus on the scient…
    onclive · 2mo ago↗ source
  • Radiopharmaceutical Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono open the discussion by reviewing the evolving role of radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC) and outlining how these…
    onclive · 2mo ago↗ source
  • Dr Postow on an Ideal Post-ICI Monitoring Framework in Melanoma
    Michael A. Postow, MD, discusses the importance of long-term multidisciplinary follow-up for patients with melanoma treated with ICIs.
    onclive · 2mo ago↗ source
  • Dr Postow on the Timing of Delayed or Re-Emergent irAEs in Melanoma
    Michael A. Postow, MD, discusses the evolving understanding of ICIs in melanoma and the unique toxicity profiles associated with these agents.
    onclive · 2mo ago↗ source
  • GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026
    We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.
    onclive · 2mo ago↗ source
  • Second Clinical Scenario - Progressive Disease Despite Hematocrit Control
    Polycythemia vera symptoms like fatigue and aquagenic itching signal active disease; experts urge objective tracking and tailored therapy beyond phlebotomy.
    onclive · 2mo ago↗ source
  • A year after Vertex’s big launch, pain drug research faces a pivotal moment
    Journavx revived an area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?
    BioPharma Dive · 2mo ago↗ source
  • Dr Silbermann on Clinical Trial Design Considerations in Multiple Myeloma
    Rebecca Silbermann, MD, MMS, outlines key trial design considerations in multiple myeloma, including supportive care measures and end point selection.
    onclive · 2mo ago↗ source
  • Dr Randall on the Rationale for Investigating CSF-1R Inhibition in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 2mo ago↗ source
  • The OncFive: Top Oncology Articles for the Week of 5/3
    The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.
    onclive · 2mo ago↗ source
  • FDA Approves Zenocutuzumab for NRG1 Fusion+ Cholangiocarcinoma
    onclive · 2mo ago↗ source
  • Dr Mauro on the Significance of Alternative TKI Formulations in CML
    Michael Mauro, MD, details the FDA approval of the small-molecule formulation of dasatinib and other alternate TKI formulations in chronic myeloid leukemia.
    onclive · 2mo ago↗ source