FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatm...
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarke...
FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer.
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.
FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as they apply to hemp-d...
President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in ...
