Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

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

Mayo Clinic, IgniteData collaborate to deploy data transfer platform

IgniteData announced a collaboration with Mayo Clinic to deploy its Archer platform across multiple sites in the U.S., aiming to improve the management of clinical trial data by enhancing the transfer of information from Electronic Health Records to Electronic Data Capture systems.

October 25, 2024

Vol.50 No.40

In Brief

CEORT, Paradigm Health launch PACT Collective, expand clinical trial access and diversity

CEO Roundtable on Cancer and Paradigm Health Inc. announced a strategic partnership to launch the Partnership for Access, Collaboration, and Trust Collective. This pioneering initiative aims to break down barriers and create equitable access to oncology clinical trials, particularly for African American, Hispanic, and other underrepresented patient groups.

October 25, 2024

Vol.50 No.40

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

Drugs & Targets

FDA approves Vyloy+chemo for gastric or GEJ junction adenocarcinoma with CLDN18.2-positive tumors

FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.

October 25, 2024

Vol.50 No.40

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

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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

Mayo Clinic, IgniteData collaborate to deploy data transfer platform

CEORT, Paradigm Health launch PACT Collective, expand clinical trial access and diversity

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

FDA approves Vyloy+chemo for gastric or GEJ junction adenocarcinoma with CLDN18.2-positive tumors

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