FDA has issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.
European Commission has approved Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of adults with metastatic squamous non-small cell lung cancer.
FDA has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy (Abraxane [nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1, as determined by an FDA-approved test.
FDA has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor–2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Myriad Genetics Inc. said the Medicare Administrative Contractor Palmetto GBA MolDx has issued a final local coverage determination for the myPath Melanoma test to help physicians provide a definitive diagnosis when a suspicious skin lesion is equivocal based upon histopathology.
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.
