FDA grants Sumitomo Pharma America a fast track designation for DSP-5336 and its use in treating certain patients with relapsed or refractory acute my...
FDA posts a guidance entitled Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients One Month of ...
Lexeo Therapeutics says it will explore with FDA the potential to seek accelerated approval for LX2006 and its use in treating Friedreich ataxia cardi...
A federal court sentences pharmaceutical marketer Quintan Cockerell to two years and five months in prison and orders him to pay over $59 million in r...
CDRH announces new organizational changes to help it meet commitments under the Medical Device User Fee Amendments reauthorization and other strategic...
Baxter recalls its Life200 Ventilator System due to the potential for battery failure involving its charging dongle.
FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.
Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical artificial intelligen...
