[ Price : $8.95]
FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.[ Price : $8.95]
FDA grants the Experimental Drug Development Center a fast-track designation for EBC-129 and its use for treating pancreatic ducta...[ Price : $8.95]
FDA grants Beam Therapeutics an orphan drug designation for BEAM-302, a liver-targeting lipid-nanoparticle that is designed to cor...[ Price : $8.95]
FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are bei...[ Price : $8.95]
Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secr...[ Price : $8.95]
FDA publishes two guidances relating to the CDRH/CBER Q-submission process.[ Price : $8.95]
GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase...[ Price : $8.95]
CDERs Accelerating Rare Disease Cures online newsletter says there were 26 orphan drug approvals in 2024 and lists four approvals ...