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34 stories matching this filter · ← front page

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  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
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Endocrinology & Metabolism320
Ophthalmology313
Pain308
Infectious Disease300
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 3d agoDealPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 4d agoApprovalPositive↗ source
  • Expedition Therapeutics raises $115M Series B to fund phase 2 COPD trial of DPP1 inhibitor
    Expedition Therapeutics, backed by Sanofi, announced a $115 million Series B financing round. The round was led by General Atlantic with participation from RA Capital, Vivo Capital, and existing i…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Smith & Nephew lowers 2026 sales outlook as US knee implant revenue falls 7%
    Smith & Nephew announced a revision to its 2026 sales outlook, now expecting underlying revenue growth of about 4% versus the prior 6% target. The change follows a second‑quarter report showing re…
    Fierce Biotech · 6d agoEarningsNegative↗ source
  • Latigo Biotherapeutics targets non-opioid pain market with $247 M IPO
    Latigo Biotherapeutics announced details of its planned initial public offering, aiming to raise roughly $247 million to advance its pipeline of non-opioid pain treatments. The company intends to…
    Fierce Biotech · 7d agoDealPositive↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Hansoh and GSK's B7-H3 ADC shows progression-free survival benefit in phase 3 osteosarcoma trial in China
    Hansoh Pharmaceutical, in partnership with GSK, announced that its B7‑H3‑directed antibody‑drug conjugate (ADC) met the primary endpoint in a phase 3 study of relapsed osteosarcoma patients in Chin…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Incyte drops phase-1 JAK2 inhibitor to focus on next-generation candidates
    Incyte announced it is abandoning its phase-1 JAK2V617F inhibitor, INCB160058, which was being tested in patients with myeloproliferative neoplasms. The decision was disclosed in the company's sec…
    Fierce Biotech · 13d agoNegative readoutNegative↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 19d agoRegulatoryPositive↗ source
  • Latigo preps IPO to fund non-opioid pain drug rival to Vertex’s Journax
    Latigo Biotherapeutics is preparing to go public in order to bankroll the development of its clinical-stage pipeline of non-opioid pain management drugs.
    Fierce Biotech · 22d 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…
    fda press · 1mo 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
  • 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 · 2mo 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 · 3mo 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 · 3mo 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 · 3mo ago↗ source