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263 stories matching this filter · ← front page

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  • Chutes & Ladders—Cue lines up new CMO and research head
    Cue Biopharma is tapping in a new chief medical officer and head of R&D in Dominic Borie, M.D., Ph.D., a physician-scientist with over two decades of industry experience.
    Fierce Biotech · 13d ago↗ source
  • 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 · 13d 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.
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26
fda press21
fda recalls20
fda medwatch16
Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
Fierce Biotech · 13d ago
↗ source
  • Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
    B. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components
    fda medwatch · 13d ago↗ source
  • Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
    Saline, Lidocaine and Bupivacaine from affected convenience kits should not be used.
    fda medwatch · 13d 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 · 14d 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 · 14d 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 · 14d 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 · 14d ago↗ source
  • Early Alert: Ventilator Issue from Resmed
    Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death
    fda medwatch · 14d 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 · 15d ago↗ source
  • Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
    Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
    fda medwatch · 15d 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 · 16d ago↗ source
  • Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
    The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
    fda medwatch · 16d ago↗ source
  • Early Alert: Convenience Kit Issue from Medical Action Industries
    Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
    fda medwatch · 20d ago↗ source
  • Early Alert: Convenience Kits Issue from Medline
    Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
    fda medwatch · 20d ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 22d ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 22d ago↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 23d ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 27d ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 27d 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
  • Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC
    Joshua J. Meeks, MD, PhD, discusses data from a real-world study of BCG retreatment after BCG failure in NMIBC.
    onclive · 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
  • Preoperative Intravesical Mitomycin-C Before TURBT Cuts Recurrence Risk by 77% in NMIBC Over 5 Years
    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