FDA warns South Koreas ReBom Co. about CGMP violations in its manufacturing of OTC drugs.
Inspire Medical Systems recalls its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can disrupt therapy.
Federal Register notice: FDA makes available a revised draft guidance entitled Addressing Misinformation About Medical Devices and Prescription Drugs:...
Federal Register notice: FDA makes available a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products...
FDA warns Denver, CO-based Optikem about CGMP violations in its production of finished drugs.
CBER publishes an updated 2024 guidance agenda with 20 listings.
Elevar Therapeutics says that after a meeting with FDA it is ready to resubmit its NDA for rivoceranib in combination with camrelizumab as a first-lin...
FDA grants Obsidian Therapeutics a fast track designation for OBX-115, a T cell immunotherapy in combination with a pharmacologically regulatable memb...
