FDA says it received 803 medical device reports on Bayers withdrawn Essure birth control implant in 2024, the lowest number since the device was pulle...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...
FDA warns San Diego-based Dexcom about Quality System violations in its production of unapproved glucose monitors.
FDA warns Indias Aspen Biopharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
