AstraZeneca says new study data on Tagrisso (osimertinib) show an improved overall survival trend in certain patients with non-small cell lung cancer....
FDA warns Denver, CO-based Exer Labs about illegally marketing its Exer Scan device that has Quality System Regulation violations.
FDA says it received 803 medical device reports on Bayers withdrawn Essure birth control implant in 2024, the lowest number since the device was pulle...
A Buchanan Ingersoll & Rooney petition asks FDA to continue the product-specific guidance restrictions on ANDAs citing Waylis cancer drug Tabloid as t...
The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy presentations in a Web page for its Lytgobi.
FDA sends Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apnea.
Johnson & Johnson says Rybrevant outperformed AstraZenecas Tagrisso in a head-to-head study in the first-line treatment of patients with locally advan...
Covidien recalls its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns if a component becomes...
