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4 stories matching this filter · ← front page

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STAT1670Endpoints1315Fierce Biotech632BioSpace632BioPharma Dive494raps211onclive165fda recalls108fda medwatch
therapy area
allOncology11784Rare Disease2960Immunology2721Cardiology2404Pulmonology2054Hematology2004Vaccines1729Psychiatry & CNS
  • FDA appoints new oncology chief, pledges ongoing innovation; approves treatments for two rare genetic disorders
    The Food and Drug Administration has announced a new leader for its Oncology Center of Excellence. The appointee emphasized a continued focus on innovative cancer therapies and collaborative resear…
    raps · 1mo agoRegulatoryPositive↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 3mo agoNegative↗ source
100
globenewswire health73
fda press56
1141
Ophthalmology906
Endocrinology & Metabolism729
Pain702
Nephrology698
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 3mo agoRegulatoryNeutral↗ source