CBER director Vinay Prasad says FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapies, aimed at treatin...
FDA announces new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs.
A Friends of Cancer Research working group suggests ways to overcome challenges in selecting standard of care comparators for oncology multi-regional ...
FDA releases the form FDA-483 with four observations from an inspection at the Zydus drug manufacturing facility in Baddi, India.
FDA issues a clinical hold on Intellia Therapeutics MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran after the company disclosed Grad...
FDA grants Dewpoint Therapeutics an orphan drug designation for DPTX3186 and its use in potentially treating gastric cancer.
FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) testing.
FDA accepts for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotreotide injection, ind...
