FDA grants a de novo marketing authorization for Helius Medicals Portable Neuromodulation Stimulator, indicated for use as a short-term treatment for ...
FDA sends Merck a complete response letter on a supplemental BLA for Keytruda, the companys anti-PD-1 therapy for treating certain patients with high-...
CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth risk is not persuasive and will not change its course to with...
FDA Review posts the Federal Register notices for the week ending 3/26/2021.
Federal Register notice: FDA announces the user fee rates under the Over-the-Counter Monograph Drug User Fee Program for fiscal year 2021.
Federal Register notice: FDA announces a 5/6 Arthritis Advisory Committee meeting. Pto discuss a ChemoCentryx NDA for avacopan oral capsules, indicate...
Federal Register notice: FDA issues an order to debar Ursula Wing for a period of five years from importing or offering to import any drug into the U....
Federal Register notice: FDA publishes a list of seven information collections that have been approved by OMB.