FDA has accepted the New Drug Application for TLX101-CDx (Pixclara), an agent for the imaging of glioma.
The European Commission has approved two new indications for Keytruda (pembrolizumab), an anti-PD-1 therapy, in gynecologic cancers.
The European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of trifunctional anti-CD3 x anti-EpCAM antibody Korjuny (catumaxomab) for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.
The European Medicine Agency Committee for Medicinal Products for Human Use issued positive opinions recommending an extended authorization for Tevimbra (tislelizumab) in gastric or gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
EMA has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia and Xgeva (denosumab).
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.
FDA granted 510(k) clearance to GE HealthCare’s MIM Software tool to calculate the absorbed dose of radionuclides using a Monte Carlo method.
AML Express, a next-generation sequencing assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukemia, was announced by NeoGenomics Inc.
