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.
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.
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.
Scemblix (asciminib) was granted accelerated approval by FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
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.
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.
FDA has accepted the New Drug Application for TLX101-CDx (Pixclara), an agent for the imaging of glioma.
Jaguar Health Inc. said that its unit Napo Pharmaceuticals has initiated the commercial launch of the FDA-approved oral mucositis prescription product Gelclair in the U.S.
FDA approved Itovebi (inavolisib) with palbociclib (Ibrance) and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
FDA approved an Investigational Device Exemption application to initiate a multi-center study for the treatment of recurrent cutaneous squamous cell carcinoma in immunocompromised patients using the Alpha DaRT.
