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74 stories matching this filter · ← front page

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  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 8h agoPositive readoutPositive↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 2d agoCRLNegative↗ source
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fda recalls39
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Psychiatry & CNS677
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Infectious Disease320
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 9d agoNeutral↗ source
  • Merck to test experimental sac-TMT antibody-drug conjugate with Keytruda in lung cancer trial
    Merck announced it will start a clinical trial testing its experimental antibody-drug conjugate sac-TMT together with the immunotherapy Keytruda in patients with lung cancer. The study will assess…
    Endpoints · 9d agoNeutral↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 17d agoCRLNegative↗ source
  • FDA approves Nuvalent lung cancer drug shortly after GSK completes $10.6 billion acquisition
    The FDA announced Wednesday that it has approved a lung cancer medicine from Nuvalent, marking a key regulatory milestone for the biotech. The clearance arrived just a week after GlaxoSmithKline c…
    Endpoints · 22d agoApprovalPositive↗ source
  • AstraZeneca to take rights to Dizal's lung cancer pill Zegfrovy
    AstraZeneca is set to pay Dizal Pharmaceutical, which it part-owns, $600 million upfront for worldwide development and sales rights to the lung cancer drug Zegfrovy. The UK pharma said Tuesday that…
    Endpoints · 1mo 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 · 1mo 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 · 1mo ago↗ source
  • UK price watchdog recommends against Amgen's Lumakras in lung cancer
    The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institute…
    Endpoints · 1mo ago↗ source
  • Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships
    Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZ…
    Endpoints · 1mo ago↗ source
  • Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study
    Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit…
    Endpoints · 1mo 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 · 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
  • Trodelvy misses in lung cancer, but Gilead and Merck have an HIV success
    Gilead Sciences and Merck have reported a hit and a miss for their Phase 3 HIV and lung cancer programs, respectively, but investors were largely braced for impact, according to Wall Street. The pa…
    Endpoints · 2mo ago↗ source
  • GSK to acquire Nuvalent and its two cancer drugs under FDA review for $10.6B
    GSK is making one of the largest biotech acquisitions in its history to gain access to two experimental lung cancer medicines that are due for FDA approval decisions later this year. The UK drugmak…
    Endpoints · 2mo ago↗ source
  • #ASCO26: Summit, Akeso drug reduces death by 34% in China lung cancer study
    CHICAGO — The leading drug in biopharma's hottest immunotherapy race reduced the risk of death by 34% in previously untreated Chinese lung cancer patients, compared to standard immunotherapy plus c…
    Endpoints · 2mo ago↗ source
  • Acceleron leaders and Westlake jumpstart new IPF biotech
    After success with the drug Winrevair, a band of entrepreneurs has found their next challenge in a difficult-to-treat lung disease. On Tuesday, Oorja Bio launched with a $30 million Series A round,…
    Endpoints · 2mo ago↗ source
  • Full-Life Technologies raises $150M; Quince's reboot with pulmonary drug
    Plus, news about Accro Bioscience, Hansa Biopharma, Shanghai Best-Link Bioscience and UCB. Full-Life Technologies gets $150M: The radiotherapy company has raised $110 million in a Series D round an…
    Endpoints · 2mo ago↗ source
  • MET Alterations in NSCLC: Amplification, Mutations, and Therapeutic Strategies
    Decode MET-altered lung cancer: amplification, exon 14 skipping and co-mutations, plus evolving targeted therapies and tumor board insights.
    onclive · 3mo ago↗ source
  • UCSF Receives Major Gift to Advance Research and Modernization
    Kathy Chiao and Ken Hao commit $100 million for major capital projects, cancer research, and innovation at UCSF — building on a recent $75 million gift to UC Davis for veterinary medicine.
    onclive · 3mo ago↗ source
  • How Reimagined Research Endeavors Intersect With Dignified End-of-Life Care: With D. Ross Camidge, MD, PhD; and Charles D. Blanke, MD, FACP, FASCO
    Drs Camidge and Blanke discuss Dr Blanke's career path from pioneering targeted cancer therapies to becoming a leading advocate for medical aid in dying.
    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
  • Temple Health’s Fox Chase Cancer Center and Labcorp Collaborate to Test Ultra-Sensitive Blood-Based Assay for Early-Stage Lung Cancer Recurrence Risk
    A Fox Chase Cancer Center study will evaluate a tumor-informed, whole-genome sequencing–based test to assess recurrence risk in early-stage NSCLC.
    onclive · 3mo ago↗ source
  • EGFR-Mutated NSCLC: Mechanism and Clinical Role of TROP2-Directed ADCs
    In this segment, Dr. Sands asks the panel to discuss the emerging role of TROP2-directed antibody–drug conjugates in EGFR-mutated non-small cell lung cancer. Dr. Wakelee and Dr. Cooper explain that…
    onclive · 3mo ago↗ source