FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

Alex Morozov named chief medical officer at Pi Health

Alex Morozov was named the first chief medical officer of Pi Health, an oncology clinical trial and research technology company.

August 09, 2024

Vol.50 No.32

Drugs & Targets

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA has approved Voranigo (vorasidenib), an isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 inhibitor, for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

August 09, 2024

Vol.50 No.32

Drugs & Targets

FDA approves Lymphir immunotherapy for r/r CTCL

FDA has approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma after at least one prior systemic therapy.

August 09, 2024

Vol.50 No.32

Drugs & Targets

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Labcorp announced it has received de novo marketing authorization from FDA for PGDx elio plasma focus Dx—the industry’s first and only kitted, pan-solid tumor liquid biopsy test.

August 09, 2024

Vol.50 No.32

Clinical Trials & Tribulations

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).

Language barriers hinder diverse recruitment to clinical trials

Underrepresentation of racial and ethnic minority populations in cancer clinical trials persists partly because translation and interpretation services and resources are unavailable or inadequate in the United States, according to a Children’s Oncology Group study led by Columbia University School of Nursing.

August 02, 2024

Vol.50 No.31

FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

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Alex Morozov named chief medical officer at Pi Health

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA approves Lymphir immunotherapy for r/r CTCL

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

Language barriers hinder diverse recruitment to clinical trials

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FDA clinical trial guidances touch on Biden administration’s goals for advancing development of cancer treatments

YOU MAY BE INTERESTED IN

Alex Morozov named chief medical officer at Pi Health

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA approves Lymphir immunotherapy for r/r CTCL

FDA grants de novo authorization for PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test

Of adaptive and factorial designsA biostatistician’s interpretation of last week’s ODAC

Language barriers hinder diverse recruitment to clinical trials

Can you spare 10 minutes to complete a survey?

Login

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC