Paige.AI, a start-up in computational pathology focused on building artificial intelligence received the Breakthrough Device designation from FDA.
AstraZeneca and Merck said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza tablets, as monotherapy for adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer.
Biotheranostics Inc. said its Breast Cancer Index test has received a new Medicare Local Coverage Determination [L37822] by Noridian, effective April 16.
FDA has approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use. Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.
FDA has approved Lonsurf as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
FDA approved Merck's pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with involvement of lymph node following complete resection.
FDA accepted Tanabe Research Laboratories U.S.A. Inc.'s first Investigational New Drug application to initiate a phase I trial for its Antibody Drug Conjugate TR1801-ADC (MT- 8633) in patients with cMet positive solid tumors.
FDA has accepted and granted priority review for a new supplemental Biologics License Application for KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with advanced small cell lung cancer whose disease has progressed after two or more lines of prior therapy.
FDA issued a revised draft guidance, “Use of Investigational Tobacco Products,” intended to assist tobacco product manufacturers, academic institutions and institutional review boards studying tobacco products.
The European Commission has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.