FDA issues draft guidance on expanded access to investigational drugs

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

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