FDA issues guidance on implementing decentralized elements in clinical trials

Ready or not, AI-based decision support tools are entering oncology clinics
Regulators and health systems must adapt

Urologic oncologist Wayne Brisbane thought his patient might be a good candidate for focal therapy.

November 15, 2024

FDA approves Aucatzyl for adults with r/r B-cell precursor ALL

FDA approved Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

November 15, 2024

Vol.50 No.43

Drugs & Targets

FDA approves MI Cancer Seek as a CDx test for adults and pediatric patients

FDA has approved MI Cancer Seek for use as a companion diagnostic to identify patients with cancer who may benefit from treatment with targeted therapies.

November 08, 2024

Vol.50 No.42

Regulatory News

At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference

FDA’s cancer czar Richard Pazdur had a “silver anniversary” at the agency recently. So, he invited some guests—the commissioners he had reported to under the Democratic and Republican administrations.

November 01, 2024

Vol.50 No.41

By Claire Marie Porter

Drugs & Targets

FDA approves Scemblix for newly diagnosed CML patients

Scemblix (asciminib) was granted accelerated approval by FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

November 01, 2024

Vol.50 No.41

In Brief

FDA, CBP seize $76M in illegal e-cigarettes

FDA in collaboration with U.S. Customs and Border Protection, announced the administrative seizure of approximately three million units of unauthorized e-cigarette products, with an estimated retail value of $76 million.

October 25, 2024

Vol.50 No.40

FDA issues guidance on implementing decentralized elements in clinical trials

YOU MAY BE INTERESTED IN

Ready or not, AI-based decision support tools are entering oncology clinics
Regulators and health systems must adapt

FDA approves Aucatzyl for adults with r/r B-cell precursor ALL

FDA approves MI Cancer Seek as a CDx test for adults and pediatric patients

At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference

FDA approves Scemblix for newly diagnosed CML patients

FDA, CBP seize $76M in illegal e-cigarettes

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FDA issues guidance on implementing decentralized elements in clinical trials

YOU MAY BE INTERESTED IN

Ready or not, AI-based decision support tools are entering oncology clinicsRegulators and health systems must adapt

FDA approves Aucatzyl for adults with r/r B-cell precursor ALL

FDA approves MI Cancer Seek as a CDx test for adults and pediatric patients

At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference

FDA approves Scemblix for newly diagnosed CML patients

FDA, CBP seize $76M in illegal e-cigarettes

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Ready or not, AI-based decision support tools are entering oncology clinics
Regulators and health systems must adapt