A New York federal judge orders Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until it complies with federal ...
An FDA safety alert asks patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-i...
FDA releases its latest batch of Warning Letters that includes one medical product company LifeHealth Science.
FDA Review posts product approval summaries for the week ending 5/29/2020.
CDER issues its fifth annual drug safety priorities report detailing the effort at multidisciplinary collaboration in the Center.
Federal Register notice: FDA provides notification that it approved a drug product that relied on a priority review voucher for approval Biohaven Pha...
FDA approves an Avid Radiopharmaceuticals NDA for Tauvid (flortaucipir F18) for intravenous injection, the first drug for helping image a distinctive ...
Federal Register notice: FDA makes available a final guidance #240 entitled Proprietary Names for New Animal Drugs.