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.
Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmatory study failed to de...
FDA grants Bayer-owned Asklepios BioPharmaceutical a fast track designation for AB-1005, a gene therapy candidate for treating moderate Parkinsons dis...
Federal Register notice: FDA releases two draft guidances entitled Dental Composite Resin Devices Premarket Notification (510(k)) Submissions and Den...
