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83 stories matching this filter · ← front page

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  • Windward Bio launches on Nasdaq after $175 million IPO, secures $50 million from Sanofi
    Windward Bio, a biotech developing drugs for respiratory diseases, completed its initial public offering and began trading on Nasdaq. The offering raised $175 million, with the stock opening at $1…
    Endpoints · 2h agoDealPositive↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 7d agoApprovalPositive↗ source
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Ophthalmology1079
Endocrinology & Metabolism785
Pain784
Nephrology764
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 7d agoApprovalPositive↗ source
  • Compact Medical issues recall and updated instructions for ButterflyBVM bag-valve-mask resuscitators due to bellows holes
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk problem with certain Compact Medical ButterflyBVM bag‑valve‑mask devices. Compact Medical…
    fda medwatch · 10d agoCRLNegative↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 11d agoDealNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 13d agoApprovalPositive↗ source
  • Medline orders removal of all brand beds and accessories over fire and asphyxiation hazards
    Medline has issued an urgent field safety notice indicating that all of its branded hospital beds and related components must be removed or corrected because of identified safety risks. The FDA’s…
    fda medwatch · 15d agoRegulatoryNegative↗ source
  • SystImmune/BMS and Hengrui showcase ADC data for EGFR-mutant lung cancer at ESMO
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, Li Zhang of Sun Yat-sen University Cancer Center presented early data from the HERON‑Lung01 study, highlighting an antibody‑dr…
    Endpoints · 18d agoNeutral↗ source
  • Roche's KRAS G12C inhibitor cuts death risk by 44% versus Amgen and BMS in lung cancer trial
    At the European Society for Medical Oncology meeting in Madrid, Roche presented data on its next‑generation KRAS G12C inhibitor in non‑small cell lung cancer. In a head‑to‑head study against compa…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Pfizer shifts focus after lung cancer trial setback, cites early signals in earlier-line patients; BioNTech and BMS report initial activity
    Pfizer’s late‑stage trial in non‑small cell lung cancer did not meet its primary endpoint, prompting the company to highlight a post‑hoc analysis that suggests benefit for patients treated earlier…
    Endpoints · 19d agoNeutral↗ source
  • AstraZeneca reports Tagrisso-Orpathys combo could prolong treatment for EGFR-mutant lung cancer
    At the European Society for Medical Oncology meeting, AstraZeneca said early data suggest that adding Orpathys to Tagrisso may let patients with mutant non‑small cell lung cancer continue therapy a…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Amgen's Imdelltra plus AstraZeneca's Imfinzi cuts death risk by 58% in small cell lung cancer Phase 3 trial
    Amgen reported results from a Phase 3 trial evaluating its investigational therapy Imdelltra in combination with AstraZeneca’s immunotherapy Imfinzi in patients with small cell lung cancer. The st…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 24d agoApprovalPositive↗ source
  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 24d agoRegulatoryNegative↗ source
  • Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
    The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus)…
    fda medwatch · 24d ago↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Syndax halts development of Niktimvo after Phase 2 failure in IPF trial
    Syndax announced it is stopping work on its experimental drug Niktimvo for idiopathic pulmonary fibrosis (IPF) after the compound did not meet its primary endpoints in a placebo-controlled Phase 2…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Bristol Myers reports two Phase 3 successes for fibrosis and RayzeBio drug
    Bristol Myers Squibb announced Monday that two of its late-stage trials have met primary endpoints. The first trial involved its fibrosis program, where the experimental therapy demonstrated the e…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Endeavor BioMedicines reports mid-stage trial success for IPF drug, suggests disease reversal potential
    Endeavor BioMedicines announced that its experimental therapy for idiopathic pulmonary fibrosis has met its primary goals in a Phase 2 study. The company said the mid‑stage trial showed signs that…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • ArriVent's lead lung cancer drug firmonertinib fails Phase 3 trial, shares plunge
    ArriVent BioPharma announced that its flagship EGFR inhibitor, firmonertinib, did not meet primary endpoints in a late-stage Phase 3 study for lung cancer. The trial results were released on Octobe…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 1mo agoApprovalPositive↗ source
  • Patient death raises safety concerns before Bristol Myers lung drug readout
    A patient died from a fatal liver injury while taking part in a trial of Bristol Myers Squibb's lung disease candidate. The company disclosed the incident in a May amendment to its trial documents…
    Endpoints · 1mo agoNegative↗ source
  • Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancer
    Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients. The…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source